IN.PACT BTK Randomized Study to Assess Safety and Efficacy of IN.PACT 014 vs. PTA

Randomized Study of IN.PACT 014 Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter vs. Optimal Percutaneous Transluminal Angioplasty for the Treatment of Chronic Total Occlusions in the Infrapopliteal Arteries

To assess the safety and efficacy of the paclitaxel drug-coated balloon IN.PACT 014 versus conventional optimal percutaneous transluminal angioplasty (PTA) for the treatment of patients with chronic total occlusions in the infrapopliteal arteries.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease; Critical Limb Ischemia
• Intervention / Treatment: Device: DCB; Device: PTA

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • East-Flanders
    • Dendermonde, East-Flanders, Belgium, 9200
      • AZ Sint Blasius
  • Limburg
    • Genk, Limburg, Belgium, 3600
      • ZOL GENK
• France
  • Nantes, France
    • Hopital Guillaume et Rene Laennec - Centre Hospitalier Universitaire
• Greece
  • Patras, Greece
    • University Hospital Patras
• Italy
  • Arezzo, Italy, 50200
    • Ospedale San Donato
  • Lombardy
    • Sesto San Giovanni, Lombardy, Italy, 20099
      • IRCCS Multimedica
  • Ravenna
    • Cotignola, Ravenna, Italy, 48033
      • Maria Cecilia Hospital
• Switzerland
  • Zürich, Switzerland
    • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥18 years.
2. Subject has been informed of the nature of the study, agrees to participate and has signed an EC approved consent form.
3. Female subjects of childbearing potential have a negative pregnancy test ≤7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation.
4. Subject has documented chronic Critical Limb Ischemia (CLI) in the target limb prior to the study procedure with Rutherford Clinical Category 4 or 5.
5. Subjects with documented infection grade 0-2 and ischemia grade 2-3 according to WIfi classification.
6. Life expectancy >1 year in the Investigator's opinion.
7. Reference Vessel Diameter (RVD) 2 - 4 mm, and confirmed by DUS assessment.
8. Total occlusions with total lesion length ≥ 40 mm (by visual estimate).
9. Lesion must be located in the infrapopliteal arteries and above the ankle joint.
10. Multiple lesions can be treated if located in separate vessels.
11. Presence of documented run-off to the foot.
12. Inflow free from flow-limiting lesion confirmed by angiography.
13. Successful pre-dilatation of the (entire) target lesion.

Exclusion Criteria:

1. Subject unwilling or unlikely to comply to the appropriate follow-up times for the duration of the study.
2. Planned index limb amputation above the metatarsal level, or any other planned major surgery within 30 days pre or post-procedure.
3. Lesion and/or occlusions located or extending in the popliteal artery or below the ankle joint space.
4. Significant (≥50% DS) inflow lesion or occlusion in the ipsilateral iliac, SFA and popliteal arteries left untreated.
5. Failure to obtain ≤ 30% residual stenosis in pre-existing, hemodynamically significant inflow lesions in the ipsilateral iliac, SFA and popliteal artery.
6. Prior stent(s) or bypass surgery within the target vessel(s) (including stents placed within target vessels during the index procedure prior to randomization.
7. Previous DCB procedure in the target vessel within 6 months prior to index procedure.
8. Aneurysm in the target vessel.
9. Angiographic evidence of thrombus within target limb.
10. Pre-dilatation resulted in major (≥ Grade D) flow-limiting dissection or residual stenosis > 30%.
11. Use of alternative therapy e.g. atherectomy, cutting balloon, laser, radiation therapy, stents as part of target vessel treatment.
12. Recent MI or stroke < 30 days prior to the index procedure.
13. Heart failure with Ejection Fraction < 30%.
14. Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound on the target limb.
15. Subjects with infection grade 3 and ischemia grade 0 and 1 according to the Wifi classification.
16. Subjects with neutrotrophic ulcers, heel pressure ulcers or calcaneal ulcers with a risk of major amputation.
17. Subjects with documented active osteomyelitis, excluding the phalanges, that is beyond cortical involvement of the bone per clinical judgement.
18. Impaired renal function (GFR <20 mL/min) and patients on dialysis.
19. Subject with vasculitis, systemic Lupus Erythematosus or Polymyalgia Rheumatica on active treatment.
20. Patient receiving systemic corticosteroid therapy.
21. Known allergies or sensitivities to heparin, aspirin (ASA), other anticoagulant/anti-platelet therapies which could not be substituted, and/or paclitaxel or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure.
22. The patient is currently enrolled in another investigational device or drug trial that is interfering with the endpoints of this study.
23. Female subjects who are breastfeeding at the time of enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug Coated Balloon IN.PACT 014 (DCB); Participants who receive IN.PACT 014.	Device: DCB; Drug Coated Balloon
Active Comparator: Percutaneous Transluminal Angioplasty (PTA); Participants who receive standard PTA treatment.	Device: PTA; Percutaneous Transluminal Angioplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Effectiveness Endpoint: Late Lumen Loss (LLL) at 9 Months	Late lumen loss (LLL) - The difference between minimum lumen diameter (MLD) immediately after percutaneous balloon angioplasty PTA and MLD at follow up, measured at 9 months	9 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Safety Endpoint	A composite of freedom from device- and procedure-related mortality within 30 days, freedom from major target limb amputation and freedom from clinically-driven target lesion revascularization (CD-TLR) within 9 months post-index procedure	9 Months
Major Adverse Event (MAE) Rate	defined as a composite of all-cause mortality, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR) Reported by using the event-free survival Kaplan-Meier estimate through 60 months	through 3, 6, 9, 12, 24, 36, 48 and 60 months
Functional Flow Assessment	is defined as absence of target lesion occlusion (no flow) assessed by duplex ultrasound.	at 3, 6, 9, 12, 24 and 36 months
Death of Any Cause	Death of any cause, reported by using the event-free survival Kaplan-Meier estimate through 60 months	through 3, 6, 9, 12, 24, 36, 48 and 60 months
Major Target Limb Amputation Rate	Major Target Limb Amputation rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months	through 30 days, 3, 6, 9, 12, 24, 36, 48 and 60 months
Clinically-driven Target Lesion Revascularization (CD-TLR) Rate	Clinically-driven Target Lesion Revascularization (CD-TLR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months	through 3, 6, 9, 12, 24, 36, 48 and 60 months
Mechanically-driven Target Lesion Revascularization (TLR) Rate	Mechanically-driven Target Lesion Revascularization (TLR) rate	through 37 days
Target Lesion Revascularization (TLR) Rate	Target Lesion Revascularization (TLR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months	through 3, 6, 9, 12, 24, 36, 48 and 60 months
Clinically-driven Target Vessel Revascularization (CD-TVR) Rate	Clinically-driven Target Vessel Revascularization (CD-TVR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months	through 3, 6, 9, 12, 24, 36, 48 and 60 months
Target Vessel Revascularization (TVR) Rate	Target Vessel Revascularization (TVR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months	through 3, 6, 9, 12, 24, 36, 48 and 60 months
Status of Wound Healing	Status of wound healing for baseline wounds: completely healed - improvement - unchanged - worsened - Amputation - skin graft; percentage of wounds in each category is presented for each treatment arm	at 30 days, 3, 6, 9, 12, 24 and 36 months
Rate of Thrombosis at the Target Lesion	Rate of thrombosis at the target lesion, reported by using the event-free survival Kaplan-Meier estimate through 60 months	through 30 days, 3, 6, 9, 12, 24, 36, 48 and 60 months
Device Success	Calculated as the number of IN.PACT 014 Investigational devices with successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP), divided by the total number of IN.PACT 014 Investigational devices assessed in the study	at the time of procedure
Clinical Success	Clinical success is defined as residual stenosis of ≤ 30% without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or target vessel revascularization (TVR)). If any lesion has residual stenosis > 30% or any of the complications (death, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge, then subject is not counted as having Clinical Success. Clinical success is calculated as the number of index procedures with residual stenosis of ≤ 30% by core lab (use site reported data if core lab data is not available) for all target lesions and without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge as adjudicated by CEC, divided by the number of total index procedures performed.	up to discharge visit [between index procedure and 30-day (+/- 7 days) follow-up visit. The average days until discharge was: 9 days (with a max. of 31days) in the IN.PACT 014 arm, and 6 days (with a max. of 21days) in the PTA arm.]

Collaborators and Investigators

• Sponsor: Medtronic Endovascular

Publications and helpful links

General Publications

• Liistro F, Weinberg I, Almonacid Popma A, Shishehbor MH, Deckers S, Micari A. Paclitaxel-coated balloons versus percutaneous transluminal angioplasty for infrapopliteal chronic total occlusions: the IN.PACT BTK randomised trial. EuroIntervention. 2022 Apr 1;17(17):e1445-e1454. doi: 10.4244/EIJ-D-21-00444.

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2017
• Primary Completion (Actual): October 7, 2019
• Study Completion (Actual): December 21, 2023

Study Registration Dates

• First Submitted: November 9, 2016
• First Submitted That Met QC Criteria: November 10, 2016
• First Posted (Estimated): November 15, 2016

Study Record Updates

• Last Update Posted (Actual): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 7, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Drug-eluting angioplasty balloon, Drug coated angioplasty balloon, Experimental, percutaneous transluminal angioplasty (PTA)
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Ischemia; Chronic Limb-Threatening Ischemia; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: APV-IN.PACT BTK OUS

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No