IN.PACT Global Clinical Study

The IN.PACT Global Clinical Study for the Treatment of Comprehensive Superficial Femoral and/or Popliteal Artery Lesions Using the IN.PACT Admiral™ Drug-Eluting Balloon.

The purpose of this study is to collect safety and efficacy data on the IN.PACT Admiral™ Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease in the superficial femoral and/or popliteal arteries in a "real world" patient population.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: IN.PACT Admiral™ Drug Eluting Balloon

Detailed Description

Peripheral artery disease (PAD) commonly results from progressive narrowing of the arteries in the lower extremities, usually due to atherosclerosis. Progression of PAD can result in critical limb ischemia (CLI), manifested by ischemic pain at rest or in the breakdown of the skin, resulting in ulcers or gangrene which ultimately may lead to amputation and death.

The IN.PACT Global Clinical Study aims to expand and understand the safety and efficacy data on the IN.PACT Admiral™ DEB in a real world population of subjects with intermittent claudication and/or rest pain (Rutherford class 2-3-4) due to obstructive disease of the superficial femoral and/or popliteal arteries.

• Study Type: Interventional
• Enrollment (Actual): 1535
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Fundacion Favaloro
  • Bueos Aires, Argentina
    • Clinica La Sagrada Familia
• Australia
  • Sydney, Australia, NSW 2050
    • Royal Prince Alfred Hospital
• Austria
  • Graz, Austria, 8036
    • Medizinische Universität Graz
  • Mödling, Austria, 2340
    • Landesklinikum Thermenregion Mödling
• Belgium
  • Aalst, Belgium, 9300
    • Onze-Lieve-Vrouwziekenuis
  • Bonheiden, Belgium, 2820
    • Imelda Ziekenhuis
  • Dendermonde, Belgium, 9200
    • AZ St. Blasius
  • Edegem, Belgium, 2650
    • Universitair Ziekenhuis Antwerpen
  • Genk, Belgium, 3600
    • Ziekenhuis Oost Limburg - Campus St.-Jan
  • Gent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Tienen, Belgium, 3300
    • Regionaal Ziekenhuis Heilig Hart
• Canada
  • Sherbrooke, Canada
    • Centre hospitalier universitaire Sherbrooke (CHUS)
  • Toronto, Canada
    • Toronto General Hospital
• Colombia
  • Medellin, Colombia
    • Clinica Santa Maria
  • Neiva, Colombia
    • Clinica Medilaser Neiva
• Czechia
  • Hradec Kralove, Czechia, 50005
    • Faculty Hospital Hradec Králové
• Egypt
  • Cairo, Egypt
    • As-Salam International Hospital
  • Cairo, Egypt
    • Egypt Air Hospital
• Finland
  • Helsinki, Finland
    • Helsingin Seudun Yliopistollinen Keskussairaala
• France
  • Bordeaux Cedex, France, 33076
    • Group Hospitalier Pellegrin - CHU
  • Strasbourg, France, 67000
    • Les Hospitaux Universitaires de Strasbourg
• Germany
  • Bad Krozingen, Germany, 79189
    • Herzzentrum Bad Krozingen
  • Duesseldorf, Germany
    • Augusta-Krankenhaus
  • Düsseldorf, Germany, 40472
    • Augusta Krankenhaus
  • Heidelberg, Germany, 69120
    • Universitätsklinikum Heidelberg
  • Leipzig, Germany, 04289
    • Park-Krankenhaus Leipzig
  • Leipzig, Germany, 04103
    • Universitätsklinikum Leipzig AöR
  • Münster, Germany, 48145
    • St. Franziskus Hospital GmbH
  • Rosenheim, Germany, 83022
    • RoMed Klinikum Rosenheim
  • Tübingen, Germany, 72076
    • Universitätsklinikum Tübingen
• Greece
  • Patra, Greece, TK26504
    • University Hospital of Patras
• Hungary
  • Budapest, Hungary, 1122
    • Semmelweis University
  • Kecskemét, Hungary, 6000
    • Bacs Kiskun Megyei Korhaz
• Israel
  • Haifa, Israel, 34362
    • Carmel Medical Centre
  • Petach Tikva, Israel, 49100
    • Rabin Medical Center - Beilison Hospital
• Italy
  • Catania, Italy, 95123
    • Policlinico Vittorio Emanuele
  • Palermo, Italy, 90135
    • Maria Eleonora Hospital
  • Rome, Italy, 00168
    • Policlinico Gemelli
• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center
  • Seoul, Korea, Republic of, 152-703
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of, 120-752
    • Severence Hospital
  • Suwon, Korea, Republic of, 443-380
    • Ajou University Hospital
• Lithuania
  • Kaunas, Lithuania, 50009
    • Kaunas Mecial University Clinic
• Netherlands
  • 's Hertogenbosch, Netherlands, 5223GZ
    • Jeroen Bosch Ziekenhuis
  • Arnhem, Netherlands, 6800TA
    • Rijnstate Ziekenhuis
  • Eindhoven, Netherlands, 5623EJ
    • Catharina Ziekenhuis
  • Nieuwegein, Netherlands, 3430EM
    • Sint Antonius Hospital
  • Utrecht, Netherlands, 3584CX
    • Universitair Medisch Centrum Utrecht
• Poland
  • Katowice, Poland, 40-519
    • Euromedic Medical Center
  • Szczecin, Poland, 70-111
    • Samodzielny Publiczny Szpital Kliniczny Nr 2
• Portugal
  • Lisbon, Portugal, 1169-024
    • Hospital Santa Marta
• Russian Federation
  • Moscow, Russian Federation, 121374
    • City Clinical Hospital named after M.E. Zhadkevich
• Singapore
  • Singapore, Singapore, 529889
    • Changi General Hospital
• Slovakia
  • Banská Bystrica, Slovakia, 97401
    • Stredoslovensky ustav srdcovych a cievnych chorob (SUSCCH)
  • Bratislava, Slovakia, 83348
    • Národný ústav srdcových a cievnych chorôb a.s. (NUSCH)
  • Kosice, Slovakia, 04011
    • Východoslovenský ústav srdcových a cievnych chorôb, a.s.(VUSH)
• Slovenia
  • Maribor, Slovenia, 2000
    • University Medical Centre Maribor
• Sweden
  • Solna, Sweden, 17176
    • Karolinska Universitetssjukhuset
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital - Universitätsspial Bern
  • Fribourg, Switzerland, 1708
    • Hopital Cantonal HFR
  • Luzern, Switzerland, 6000
    • Kantonspital Luzern
• United Kingdom
  • Manchester, United Kingdom, M139WL
    • Manchester Royal Infirmary
  • Sheffield, United Kingdom, S57AU
    • Northern General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

General inclusion Criteria:

• Age ≥ 18 years or minimum age as required by local regulations.
• Subject with documented diagnosis of peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and/or popliteal artery (PA) (including P1, P2, P3) classified as Rutherford class 2-3-4.
• Angiographically documented single or multiple lesions/occlusions (de novo or re-stenotic lesion(s) or in-stent restenosis) within the target vessels with a minimum lesion length of 2 cm including bilateral disease if both limbs are treated within 35 days.

General exclusion Criteria:

• High probability of non-adherence to Clinical Investigation Protocol follow-up requirements.
• Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations).
• Lesion within or adjacent to an aneurysm or presence of a popliteal aneurysm.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: IN.PACT Admiral DEB; The subjects in this trial will be treated with the IN.PACT Admiral™ percutaneous transluminal angioplasty (PTA) paclitaxel drug eluting balloon (hereinafter referred as "IN.PACT Admiral™ DEB")manufactured by Medtronic. The IN.PACT Admiral™ is a CE (Conformité Europeénne, European Confirmity) marked medical device utilized within its intended use in the IN.PACT Global trial.

Device: IN.PACT Admiral™ Drug Eluting Balloon; IN.PACT Admiral™ percutaneous transluminal angioplasty (PTA) paclitaxel drug eluting balloon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Cohort ITT - Primary Effectiveness Endpoint	Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: • Any re-intervention within the target lesion(s) due to symptoms or drop of ABI ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.	12 months
Clinical Cohort ITT - Primary Safety Endpoint	A composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and TLR within 12 months post-index procedure.	12 months
Imaging Cohort ITT - Primary Effectiveness Endpoint	Primary Patency within 12 months post-index procedure, which is defined as: Freedom from clinically-driven TLR and; Freedom from restenosis as determined by DUS Peak Systolic Velocity Ratio (PSVR) ≤ 2.4.Restenosis determined by either PSVR >2.4 as assessed by an independent DUS core lab or >50% stenosis as assessed by an independent angiographic core lab.	12 months
150mm DEB ITT Cohort - Primary Effectiveness Endpoint	Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: • Any re-intervention within the target lesion(s) due to symptoms or drop of ABI ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Cohort ITT - MAEs	MAE (Major Adverse Events) is defined as all-cause mortality, clinically-driven TVR (Target Vessel Revascularization), major target limb amputation, thrombosis at the target lesion site.	12 months
Clinical Cohort ITT - TLR	Any Target lesion revascularisation	12 months
Clinical Cohort ITT - TVR	Any Target vessel revascularisation	12 months.
Clinical Cohort ITT - Device Success	Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP)	Index-procedure
Clinical Cohort ITT - Clinical Success	Clinical success is defined as procedural success without procedural complications (mortality, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge	prior to discharge
Clinical Cohort ITT - MAEs	MAE (Major Adverse Events) is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.	60 months
Clinical Cohort ITT - Clinically-driven TLR	Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.	60 months
Clinical Cohort ITT - TVR		60 months
Clinical Cohort ITT - TLR		60 months
Clinical Cohort ITT - Time to First Clinically-driven TLR (Days)		60 months
Clinical Cohort ITT - MAEs	Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 30 days.	30 days
Clinical Cohort ITT - MAEs	MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site	6 Months
Clinical Cohort ITT - MAEs	MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.	24 Months
Clinical Cohort ITT - MAEs	MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.	36 Months
Clinical Cohort ITT - MAEs	MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.	48 Months
Clinical Cohort ITT - Clinically-driven TLR	Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.	30 days
Clinical Cohort ITT - Clinically-driven TLR	Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.	6 Months
Clinical Cohort ITT - Clinically-driven TLR	Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.	24 Months
Clinical Cohort ITT - Clinically-driven TLR	Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.	36 Months
Clinical Cohort ITT - Clinically-driven TLR	Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.	48 Months
Clinical Cohort ITT - TLR	Any Target lesion revascularisation	6 Months
Clinical Cohort ITT - TLR	Any Target lesion revascularisation	24 Months
Clinical Cohort ITT - TLR	Any Target lesion revascularisation	36 Months
Clinical Cohort ITT - TLR	Any Target lesion revascularisation	48 Months
Clinical Cohort ITT - TVR	Any Target lesion revascularisation	24 Months
Clinical Cohort ITT - TVR	Any Target lesion revascularisation	36 Months
Clinical Cohort ITT - TVR	Any Target lesion revascularisation	48 Months
Clinical Cohort ITT - TVR	Any Target lesion revascularisation	6 Months
Clinical Cohort ITT - Time to All-cause Mortality Through 60 Months Post-index Procedure.	All-cause mortality is reported by using the survival estimate of all cause mortality through 60 months	60 months
Clinical Cohort ITT - Primary Sustained Clinical Improvement	Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects	6 Months
Clinical Cohort ITT - Primary Sustained Clinical Improvement	Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects	12 Months
Clinical Cohort ITT - Primary Sustained Clinical Improvement	Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects	24 Months
Clinical Cohort ITT - Primary Sustained Clinical Improvement	Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects	36 Months
Clinical Cohort ITT - Secondary Sustained Clinical Improvement	Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	6 Months
Clinical Cohort ITT - Secondary Sustained Clinical Improvement	Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	12 Months
Clinical Cohort ITT - Secondary Sustained Clinical Improvement	Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	24 Months
Clinical Cohort ITT - Secondary Sustained Clinical Improvement	Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	36 Months
Clinical Cohort ITT - Immediate Hemodynamic Improvement at Post-index Procedure	Immediate hemodynamic improvement is defined as an ABI improvement of ≥ 0.1 or to an ABI ≥ 0.9	Post procedure
Clinical Cohort ITT - Sustained Hemodynamic Improvement	Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	6 Months
Clinical Cohort ITT - Sustained Hemodynamic Improvement	Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	12 Months
Clinical Cohort ITT - Sustained Hemodynamic Improvement	Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	24 Months
Clinical Cohort ITT - Sustained Hemodynamic Improvement	Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	36 Months
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)		6 Months
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)		12 Months
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)		24 Months
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)		36 Months
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)	The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.	6 Months
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)	The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.	12 Months
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)	The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.	24 Months
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)	The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.	36 Months
Clinical Cohort ITT - Procedural Success	Procedural Success is defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by visual estimate	at procedure
Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 2.0) of the Target Lesion		at 12 months, or at the time of re-intervention
Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 3.4) of the Target Lesion		At 12 months, or at the time of re-intervention
150mm DEB ITT Cohort - MAEs	Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 30 days.	30 days
150mm DEB ITT Cohort - MAEs	Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 6 months.	6 months
150mm DEB ITT Cohort - MAEs	Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 12 months.	12 months
150mm DEB ITT Cohort - MAEs	Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 24 months.	24 months
150mm DEB ITT Cohort - MAEs	Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 36 months.	36 months
150mm DEB ITT Cohort - MAEs	Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 48 months.	48 months
150mm DEB ITT Cohort - MAEs	Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 60 months.	60 months
150mm DEB ITT Cohort - Clinically-driven TLR	Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.	30 days
150mm DEB ITT Cohort - Clinically-driven TLR	Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.	6 months
150mm DEB ITT Cohort - Clinically-driven TLR	Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.	24 months
150mm DEB ITT Cohort - Clinically-driven TLR	Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.	36 months
150mm DEB ITT Cohort - Clinically-driven TLR	Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.	48 months
150mm DEB ITT Cohort - Clinically-driven TLR	Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.	60 months
150mm DEB ITT Cohort - TLR	Any Target lesion revascularisation	6 Months
150mm DEB ITT Cohort - TLR	Any Target lesion revascularisation	12 Months
150mm DEB ITT Cohort - TLR	Any Target lesion revascularisation	24 Months
150mm DEB ITT Cohort - TLR	Any Target lesion revascularisation	36 Months
150mm DEB ITT Cohort - TLR	Any Target lesion revascularisation	48 Months
150mm DEB ITT Cohort - TLR	Any Target lesion revascularisation	60 Months
150mm DEB ITT Cohort - TVR	Any Target lesion revascularisation	6 Months
150mm DEB ITT Cohort - TVR	Any Target lesion revascularisation	12 Months
150mm DEB ITT Cohort - TVR	Any Target lesion revascularisation	24 Months
150mm DEB ITT Cohort - TVR	Any Target lesion revascularisation	36 Months
150mm DEB ITT Cohort - TVR	Any Target lesion revascularisation	48 Months
150mm DEB ITT Cohort - TVR	Any Target lesion revascularisation	60 Months
150mm DEB ITT Cohort - Time to First Clinically-driven TLR (Days)		60 months
150mm DEB ITT Cohort - Time to All-cause Mortality Through 60 Months Post-index Procedure.	All-cause mortality is reported by using the survival estimate of all-cause mortality through 60 months	60 months
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement	Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	6 months.
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement	Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	12 months.
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement	Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	24 months
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement	Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	36 months
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement	Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	6 Months
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement	Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	12 Months
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement	Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	24 Months
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement	Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	36 Months
150mm DEB ITT Cohort - Immediate Hemodynamic Improvement at Post-index Procedure	Immediate hemodynamic improvement is defined as an ABI improvement of ≥ 0.1 or to an ABI ≥ 0.9	Post procedure
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement	Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	6 Months
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement	Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	12 Months
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement	Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	24 Months
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement	Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	36 Months
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)		6 Months
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)		12 Months
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)		24 Months
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)		36 Months
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)	The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.	6 Months
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)	The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.	12 Months
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)	The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.	24 Months
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)	The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.	36 Months
150mm DEB ITT Cohort - Device Success	Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP)	Index-procedure
150mm DEB ITT Cohort - Procedural Success	Procedural Success is defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by visual estimate	at procedure
150mm DEB ITT Cohort - Clinical Success	Clinical success is defined as procedural success without procedural complications (mortality, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge	prior to discharge
Clinical Cohort ITT - All-cause Mortality		30 days
Clinical Cohort ITT - All-cause Mortality		6 Months
Clinical Cohort ITT - All-cause Mortality		12 Months
Clinical Cohort ITT - All-cause Mortality		24 Months
Clinical Cohort ITT - All-cause Mortality		36 Months
Clinical Cohort ITT - All-cause Mortality		48 Months
Clinical Cohort ITT - All-cause Mortality	The difference in death count calculation between the compliance table (participant flow: 253 deaths) and the event table (244 deaths) is explained as follow: Calendar days (365/year) is used for compliance table whereas 360-day annual cutoff is used for event rate calculation; Compliance table used visit window as specified by protocol (60 days for 5-year follow-up) whereas, not window is used for event rate calculation; Nine patients died between 1801 and 1885 (1825 + 60) and were therefore not included in the 5-year death rate summary but were included in the compliance summary for patients that died through the upper window of the 60 month visit.; The denominator of 1215 for 1800-day event rate includes those who had an event within 1800 days and those who did not have any event but had at least 1740 days of follow-up (1740 is the low bound of the 60-day visit window from the target day of 1800)	60 Months
Clinical Cohort ITT - Clinically-driven TVR	Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.	30 days
Clinical Cohort ITT - Clinically-driven TVR	Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.	6 Months
Clinical Cohort ITT - Clinically-driven TVR	Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.	12 Months
Clinical Clinical Cohort ITT - Clinically-driven TVR	Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.	24 Months
Clinical Cohort ITT - Clinically-driven TVR	Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.	36 Months
Clinical Cohort ITT - Clinically-driven TVR	Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.	48 Months
Clinical Cohort ITT - Clinically-driven TVR	Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.	60 Months
Clinical Cohort ITT - Major Target Limb Amputation		30 days
Clinical Cohort ITT - Major Target Limb Amputation		6 Months
Clinical Cohort ITT - Major Target Limb Amputation		12 Months
Clinical Cohort ITT - Major Target Limb Amputation		24 Months
Clinical Cohort ITT - Major Target Limb Amputation		36 Months
Clinical Cohort ITT - Major Target Limb Amputation		48 Months
Clinical Cohort ITT - Major Target Limb Amputation		60 Months
150mm DEB ITT Cohort - All-cause Mortality		30 days
150mm DEB ITT Cohort - All-cause Mortality		6 Months
150mm DEB ITT Cohort - All-cause Mortality		12 Months
150mm DEB ITT Cohort - All-cause Mortality		24 Months
150mm DEB ITT Cohort - All-cause Mortality		36 Months
150mm DEB ITT Cohort - All-cause Mortality		48 Months
150mm DEB ITT Cohort - All-cause Mortality		60 Months
150mm DEB ITT Cohort - Clinically-driven TVR	Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.	30 days
150mm DEB ITT Cohort - Clinically-driven TVR	Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.	6 Months
150mm DEB ITT Cohort - Clinically-driven TVR	Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.	12 Months
150mm DEB ITT Cohort - Clinically-driven TVR	Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.	24 Months
150mm DEB ITT Cohort - Clinically-driven TVR	Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.	36 Months
150mm DEB ITT Cohort - Clinically-driven TVR	Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.	48 Months
150mm DEB ITT Cohort - Clinically-driven TVR	Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.	60 Months
150mm DEB ITT Cohort - Major Target Limb Amputation		30 days
150mm DEB ITT Cohort - Major Target Limb Amputation		6 Months
150mm DEB ITT Cohort - Major Target Limb Amputation		12 Months
150mm DEB ITT Cohort - Major Target Limb Amputation		24 Months
150mm DEB ITT Cohort - Major Target Limb Amputation		36 Months
150mm DEB ITT Cohort - Major Target Limb Amputation		48 Months
150mm DEB ITT Cohort - Major Target Limb Amputation		60 Months

Collaborators and Investigators

• Sponsor: Medtronic Endovascular
• Investigators: Principal Investigator: Gary Ansel, MD, MidOhio Cardiology and Vascular Consultants; Principal Investigator: Do-Dai Do, MD, Swiss Cardiovascular Center, Inselspital; Principal Investigator: Peter Gaines, MD, Sheffield Vascular Institute; Principal Investigator: Alvaro Razuk, MD, Faculdade de Ciências Médicas da Santa Casa de São Paulo

Publications and helpful links

General Publications

• Krishnan P, Farhan S, Schneider P, Kamran H, Iida O, Brodmann M, Micari A, Sachar R, Urasawa K, Scheinert D, Ando K, Tarricone A, Doros G, Tepe G, Yokoi H, Laird J, Zeller T. Determinants of Drug-Coated Balloon Failure in Patients Undergoing Femoropopliteal Arterial Intervention. J Am Coll Cardiol. 2022 Sep 27;80(13):1241-1250. doi: 10.1016/j.jacc.2022.06.043.
• Brodmann M, Lansink W, Guetl K, Micari A, Menk J, Zeller T. Long-Term Outcomes of the 150 mm Drug-Coated Balloon Cohort from the IN.PACT Global Study. Cardiovasc Intervent Radiol. 2022 Sep;45(9):1276-1287. doi: 10.1007/s00270-022-03214-y. Epub 2022 Jul 21.
• Zeller T, Brodmann M, Ansel GM, Scheinert D, Choi D, Tepe G, Menk J, Micari A. Paclitaxel-coated balloons for femoropopliteal peripheral arterial disease: final five-year results of the IN.PACT Global Study. EuroIntervention. 2022 Dec 2;18(11):e940-e948. doi: 10.4244/EIJ-D-21-01098.
• Torsello G, Stavroulakis K, Brodmann M, Micari A, Tepe G, Veroux P, Benko A, Choi D, Vermassen FEG, Jaff MR, Guo J, Dobranszki R, Zeller T; IN.PACT Global Investigators. Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort. J Endovasc Ther. 2020 Oct;27(5):693-705. doi: 10.1177/1526602820931477. Epub 2020 Jun 25.
• Shishehbor MH, Schneider PA, Zeller T, Razavi MK, Laird JR, Wang H, Tieche C, Parikh SA, Iida O, Jaff MR. Total IN.PACT drug-coated balloon initiative reporting pooled imaging and propensity-matched cohorts. J Vasc Surg. 2019 Oct;70(4):1177-1191.e9. doi: 10.1016/j.jvs.2019.02.030.
• Reijnen MMPJ, van Wijck I, Zeller T, Micari A, Veroux P, Keirse K, Lee SW, Li P, Voulgaraki D, Holewijn S. Outcomes After Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Patients With Critical Limb Ischemia: A Post Hoc Analysis From the IN.PACT Global Study. J Endovasc Ther. 2019 Jun;26(3):305-315. doi: 10.1177/1526602819839044. Epub 2019 Apr 1.
• Tepe G, Micari A, Keirse K, Zeller T, Scheinert D, Li P, Schmahl R, Jaff MR; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease: The Chronic Total Occlusion Cohort in the IN.PACT Global Study. JACC Cardiovasc Interv. 2019 Mar 11;12(5):484-493. doi: 10.1016/j.jcin.2018.12.004.
• Schneider PA, Laird JR, Doros G, Gao Q, Ansel G, Brodmann M, Micari A, Shishehbor MH, Tepe G, Zeller T. Mortality Not Correlated With Paclitaxel Exposure: An Independent Patient-Level Meta-Analysis of a Drug-Coated Balloon. J Am Coll Cardiol. 2019 May 28;73(20):2550-2563. doi: 10.1016/j.jacc.2019.01.013. Epub 2019 Jan 25. Erratum In: J Am Coll Cardiol. 2019 Feb 28;:
• Zeller T, Brodmann M, Micari A, Keirse K, Peeters P, Tepe G, Scheinert D, Jaff MR, Rocha-Singh KJ, Li P, Schmahl R, Ansel GM; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain. Circ Cardiovasc Interv. 2019 Jan;12(1):e007730. doi: 10.1161/CIRCINTERVENTIONS.118.007730. No abstract available.
• Banerjee S, Khalili H. Drug-Coated Balloon for Long Femoropopliteal Lesions. Circ Cardiovasc Interv. 2018 Oct;11(10):e007084. doi: 10.1161/CIRCINTERVENTIONS.118.007084. No abstract available.
• Scheinert D, Micari A, Brodmann M, Tepe G, Peeters P, Jaff MR, Wang H, Schmahl R, Zeller T; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease. Circ Cardiovasc Interv. 2018 Oct;11(10):e005654. doi: 10.1161/CIRCINTERVENTIONS.117.005654.
• Ansel GM, Brodmann M, Keirse K, Micari A, Jaff MR, Rocha-Singh K, Fernandez EJ, Wang H, Zeller T; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment of Femoropopliteal Lesions Typically Excluded From Clinical Trials: 12-Month Findings From the IN.PACT Global Study. J Endovasc Ther. 2018 Dec;25(6):673-682. doi: 10.1177/1526602818803119. Epub 2018 Oct 3.
• Micari A, Brodmann M, Keirse K, Peeters P, Tepe G, Frost M, Wang H, Zeller T; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain: 2-Year Results From the IN.PACT Global Study. JACC Cardiovasc Interv. 2018 May 28;11(10):945-953. doi: 10.1016/j.jcin.2018.02.019.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (ACTUAL): April 1, 2016
• Study Completion (ACTUAL): January 17, 2020

Study Registration Dates

• First Submitted: May 24, 2012
• First Submitted That Met QC Criteria: May 29, 2012
• First Posted (ESTIMATE): May 31, 2012

Study Record Updates

• Last Update Posted (ACTUAL): March 25, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Atherosclerosis; Peripheral Arterial Disease; Superficial Femoral Artery; Drug eluting balloon; Drug coated balloon; Popliteal Femoral Artery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 10048613

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO