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

NCT02963649 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-07-08

Study results available
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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.

Conditions

  • Critical Limb Ischemia
  • Peripheral Arterial Disease

Interventions

DEVICE

DCB

Drug Coated Balloon

DEVICE

PTA

Percutaneous Transluminal Angioplasty

Sponsors & Collaborators

  • Medtronic Endovascular

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-02
Primary Completion
2019-10-07
Completion
2023-12-21

Countries

  • Belgium
  • France
  • Greece
  • Italy
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02963649 on ClinicalTrials.gov