- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02278991
Bard LifeStent and Lutonix DCB for Treatment of Long Lesions in Femoropopliteal Arteries
October 7, 2019 updated by: C. R. Bard
A Prospective, Multicenter, Single-Arm, Post-Market Study Using the Lutonix Drug Coated Balloon for Post-Dilatation of the Bard LifeStent Vascular Stent for Treatment of Long Lesions in Femoropopliteal Arteries
Objective of this study is to evaluate the safety and efficacy of Lutonix 035 Drug Coated Dilatation PTA Catheter with Bard LifeStent Vascular Stent (hereinafter referred to as LifeStent) for treatment of long (10-24 cm) lesions in the SFA and/or proximal popliteal artery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study will observe subjects presenting with claudication or ischemic rest pain (Rutherford category 2-4) and long (10-24 cm in length) native lesions in the infra-inguinal segment (superficial femoral artery [SFA] and/or proximal popliteal artery) who are candidates for stenting and pre-/post-dilatation with Drug Coated Balloon (DCB).
Study Type
Observational
Enrollment (Actual)
149
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Arnsberg, Germany, 59755
- Klinikum Arnsberg
-
Bad Bevensen, Germany, 29549
- Herz- und Gefässzentrum Bad Bevensen
-
Bad Krozingen, Germany, 79189
- Universitäts-Herzzentrum Freiburg Bad Krozingen
-
Hamburg, Germany, 22527
- Angiologikum Hamburg
-
Immenstadt, Germany, 87509
- Klinik Immenstadt
-
Kassel, Germany, 34125
- Klinikum Kassel
-
Lübeck, Germany, 23538
- UKSH - Campus Lübeck
-
Rosenheim, Germany, 83022
- RoMed Klinikum Rosenheim
-
Sonneberg, Germany, 96515
- Gefäßzentrum Sonneberg
-
Weiden, Germany, 92637
- Klinikum Weiden
-
-
-
-
-
Patras, Greece, 26504
- University General Hospital of Patras
-
-
-
-
-
Sanok, Poland, 38-500
- SPZOZ Sanok
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Hospital Patients
Description
Inclusion Criteria: Subjects will be included if all of the following inclusion criteria apply:
- Age ≥18 years;
- The subject is legally competent and able to understand the information on the study, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the Informed Consent Form (ICF);
- Rutherford Category 2-4;
- Target de novo lesion(s) or non-stented restenotic lesion(s) has angiographic evidence of ≥50% stenosis or occlusion (by visual estimate) and is amenable to treatment with LifeStent® and Lutonix DCB;
- Patients must be able to be treated with Lutonix DCB and LifeStent®;
- Total Lutonix DCB treated segment(s) of 10-24 cm in length;
- Target vessel reference diameter is 4.0-7.0 mm (by visual estimate) and able to be treated with available device size matrix;
- At least one patent native outflow artery to the ankle free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of outflow disease is NOT permitted; treatment of in-flow disease is permitted prior to treatment with LifeStent®).
- No other prior vascular interventions (including contralateral limb) within 2 weeks before and/or planned 30 days after the protocol treatment, with the exception of remote common femoral patch angioplasty separated by at least 2 cm from the target lesion;
- Female subjects of childbearing potential have a negative urine or serum pregnancy test within 7 days prior to index procedure;
- Lesion location starts ≥1 cm below the common femoral bifurcation and terminates distally ≤2 cm below the tibial plateau AND ≥1 cm above the origin of the tibioperoneal trunk.
Exclusion Criteria:
- Pregnant, lactating, or planning on becoming pregnant or men intending to father children;
- Contraindication to Lutonix DCB or LifeStent® per current IFU;
- Life expectancy of <1 year;
- Inability to take required antiplatelet/anticoagulant medications per the LifeStent® and Lutonix DCB IFU, or known contraindication (including allergic reaction) or sensitivity to contrast media, nickel, titanium or tantalum that cannot be adequately managed with pre- and post-procedure medication;
- Intended treatment of outflow disease during the index procedure;
- Intended use of laser, atherectomy or cryoplasty during index procedure;
- Sudden symptom onset, acute vessel occlusion, or acute or subacute thrombus in target vessel;
- History of stroke within 3 months;
- History of myocardial infarction, thrombolysis or angina within 2 weeks of enrollment;
- Participation in an investigational drug or another investigational device study until this study's (Lutonix LifeStent® Study) primary endpoint is reached or previous enrollment in this study;
- Another medical condition, which, in the opinion of the Investigator, may cause the patient to be noncompliant with the CIP or confound data interpretation;
- Target vessel and/or lesion involves a previously placed stent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Lutonix Drug Coated Balloon
Paclitaxel coated balloon catheter
|
Subject will receive treatment with the Lutonix Drug Coated Balloon
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary patency at 12 months.
Time Frame: 12 months
|
Primary patency is defined as the absence of target lesion restenosis and freedom from target lesion revascularization.
|
12 months
|
Freedom from the composite endpoint of death, index limb amputation, and target vessel revascularization at 30 days.
Time Frame: 30 days
|
Freedom from the composite endpoint of death, index limb amputation, and target vessel revascularization at 30 days.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Procedural success
Time Frame: Immediately after Intervention
|
Defined as attainment of ≤30% residual stenosis by quantitative angiography immediately after intervention in the absence of peri-procedural complications.
|
Immediately after Intervention
|
Technical success
Time Frame: Immediately after intervention
|
Defined as attainment of ≤30% residual stenosis by quantitative angiography.
|
Immediately after intervention
|
Device success
Time Frame: Immediately after intervention
|
Defined as successful delivery of the DCB to the target lesion and performance when used according to the clinical investigational plan.
|
Immediately after intervention
|
Freedom from Target Lesion Revascularization after 30 days, and 6, 12 and 24 months post-index procedure.
Time Frame: 30 days, 6, 12 and 24 months
|
Absence of Target Lesion Revascularization.
|
30 days, 6, 12 and 24 months
|
Freedom from TVR after 30 days, and 6, 12 and 24 months post-index procedure.
Time Frame: 30 days, 6, 12 and 24 months
|
Absence of Target Vessel Revascularization.
|
30 days, 6, 12 and 24 months
|
Change in resting ankle brachial index (ABI) from baseline to 30 days, and 6, 12 and 24 months post-index procedure
Time Frame: 30 days, 6, 12 and 24 months
|
The ABI values will be recorded and compared to the baseline values.
The ABI is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm.
A ratio of 0.9-1.3 is in the normal range.
Lower ratios indicate bad blood perfusion of the leg.
|
30 days, 6, 12 and 24 months
|
Change in Rutherford Classification from baseline to 30 days, and 6, 12 and 24 months post-index procedure
Time Frame: 30 days, 6, 12 and 24 months
|
Patients are enrolled with a Rutherford grade of 2-4 for their target leg.
The Rutherford scale is an indicator for the severity of Peripheral Vascular Disease: 0 = no symptoms, 6 = functional foot is no longer salvageable (leading to foot amputation).
|
30 days, 6, 12 and 24 months
|
All-cause death
Time Frame: 30 days, 6, 12 and 24 months
|
Death by any cause will be counted.
|
30 days, 6, 12 and 24 months
|
Amputation (above the ankle)-free survival
Time Frame: 30 days, 6, 12 and 24 months
|
Amputations above the ankle of the target leg will be counted.
|
30 days, 6, 12 and 24 months
|
Target limb reintervention for treatment of thrombosis of target vessel or embolization to its distal vasculature
Time Frame: 30 days, 6, 12 and 24 months
|
Thrombosis in the target vessel and embolizations below the target lesion will be analazed separately from other stenoses.
|
30 days, 6, 12 and 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas Zeller, Prof.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2014
Primary Completion (Actual)
September 1, 2017
Study Completion (Actual)
October 2, 2018
Study Registration Dates
First Submitted
October 28, 2014
First Submitted That Met QC Criteria
October 29, 2014
First Posted (Estimate)
October 30, 2014
Study Record Updates
Last Update Posted (Actual)
October 9, 2019
Last Update Submitted That Met QC Criteria
October 7, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CL0022-01
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
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Peripheral Artery Disease
-
Janssen Scientific Affairs, LLCHCA Research Institute, LLCRecruitingCoronary Artery Disease (CAD) | Peripheral Artery Disease (PAD)United States
-
University of NebraskaNot yet recruitingPeripheral Arterial Disease | Peripheral Vascular Disease | Peripheral Artery Disease | Peripheral Artery Occlusive DiseaseUnited States
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedStructural Heart Disease | Obstructive Coronary Artery Disease | Obstructive Peripheral Artery DiseaseUnited States
-
Michael Lichtenberg, MDCompletedPeripheral Artery Disease (PAD)Germany
-
Fangge DengRecruitingPeripheral Artery Disease (PAD)China
-
Fundacion para la Formacion e Investigacion Sanitarias...Not yet recruiting
-
Rontis Hellas SAPharmassist LtdActive, not recruitingPeripheral Artery Disease (PAD)Greece
-
Helsinki University Central HospitalCompletedPeripheral Artery Occlusive Disease | Peripheral Artery Stenosis | Peripheral Artery RestenosisFinland
-
Seung-Whan Lee, M.D., Ph.D.Active, not recruitingCatheterization, Peripheral | Popliteal Artery | Angioplasty, Balloon | Femoral ArteryKorea, Republic of
-
Boston Scientific CorporationCompletedAtherosclerosis | Peripheral Artery Disease | Plaque, Atherosclerotic | Artery Diseases, Peripheral | Occlusive Arterial DiseaseUnited States, Belgium, Canada, Japan, Austria, New Zealand
Clinical Trials on Lutonix Drug Coated Balloon
-
Seung-Whan Lee, M.D., Ph.D.Active, not recruitingCatheterization, Peripheral | Popliteal Artery | Angioplasty, Balloon | Femoral ArteryKorea, Republic of
-
C. R. BardTerminatedUse and Safety of the LUTONIX® Drug Coated Balloon Catheter in Arteries of the Lower Extremity (LEG)Peripheral Artery DiseaseMalaysia, New Zealand, Canada
-
C. R. BardCompletedPeripheral Artery DiseaseUnited States, Germany, Belgium, Austria, Switzerland
-
C. R. BardRecruitingArteriovenous FistulaUnited States, Canada
-
C. R. BardCompletedPeripheral Artery DiseaseAustria, Belgium, France, Switzerland, Germany, Italy, Greece, Spain, United Kingdom, Portugal, Saudi Arabia
-
C. R. BardTerminatedPopliteal Artery Stenosis | Popliteal Artery Occlusion | Femoral Artery Occlusion | Femoral Artery StenosisUnited States
-
C. R. BardCompletedArteriovenous FistulaUnited Kingdom, Singapore, France, Italy, Germany, Switzerland, Greece, Austria, Poland, Portugal, Saudi Arabia, Taiwan, Turkey
-
C. R. BardBard LtdCompletedPeripheral Artery DiseaseGermany, United Kingdom, Greece, Switzerland, Austria, Poland, Spain, Italy, France, Belgium
-
C. R. BardCompletedPeripheral Artery Disease | Femoropopliteal Artery Occlusion | Femoropopliteal StenosisUnited States
-
C. R. BardCompletedArteriosclerosis | Atherosclerosis | Vascular DiseaseGermany, Belgium