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IN.PACT Global Clinical Study

NCT01609296 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1535

Last updated 2021-03-25

Study results available
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Summary

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.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

IN.PACT Admiral™ Drug Eluting Balloon

IN.PACT Admiral™ percutaneous transluminal angioplasty (PTA) paclitaxel drug eluting balloon.

Sponsors & Collaborators

  • Medtronic Endovascular

    lead INDUSTRY

Principal Investigators

  • Gunnar Tepe, MD · Klinikum Rosenheim

  • Gary Ansel, MD · MidOhio Cardiology and Vascular Consultants

  • Marc Bosiers, MD · AZ Sint Blasius

  • Do-Dai Do, MD · Swiss Cardiovascular Center, Inselspital

  • Peter Gaines, MD · Sheffield Vascular Institute

  • Alvaro Razuk, MD · Faculdade de Ciências Médicas da Santa Casa de Sao Paulo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2016-04-30
Completion
2020-01-17

Countries

  • Argentina
  • Australia
  • Austria
  • Belgium
  • Canada
  • Colombia
  • Czechia
  • Egypt
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Russia
  • Singapore
  • Slovakia
  • Slovenia
  • South Korea
  • Sweden
  • Switzerland
  • United Kingdom

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 NCT01609296 on ClinicalTrials.gov