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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

NCT02963649•Medtronic Endovascular

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+3 more criteria

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%.
+13 more criteria

Locations (9)

AZ Sint Blasius

Dendermonde, East-Flanders, Belgium

ZOL Genk

Genk, Limburg, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Hopital Guillaume et Rene Laennec - Centre Hospitalier Universitaire

Nantes, France

University Hospital Patras

Pátrai, Greece

IRCCS Multimedica

Sesto San Giovanni, Lombardy, Italy

Maria Cecilia Hospital

Cotignola, Ravenna, Italy

Ospedale San Donato

Arezzo, Italy

University Hospital Zurich

Zurich, Switzerland

Key Dates

Start Date

March 2, 2017

Primary Completion Date

October 7, 2019

Completion Date

December 21, 2023

Last Updated

July 8, 2025

Enrollment

ACTUAL participants

Conditions

Critical Limb IschemiaPeripheral Arterial Disease

Interventions

DCB

DEVICE

PTA

DEVICE

Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

NCT07472049

Peripheral Arterial DiseaseChronic Limb Threatening Ischemia

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RECRUITING

Advanta VXT and Flixene PMCF Registry

NCT07161583

Peripheral Arterial Disease

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

Advanta VXT and Flixene PMCF Registry

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