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IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA)

NCT01566461 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 331

Last updated 2019-02-12

Study results available
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Summary

The purpose of the study is to demonstrate the safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) in comparison to any standard balloon for treatment of peripheral arterial disease (PAD) in the superficial femoral artery and proximal popliteal artery.

Conditions

  • Femoral Artery Stenosis
  • Popliteal Artery Stenosis
  • Femoral Artery Occlusion
  • Popliteal Artery Occlusion

Interventions

DEVICE

Drug-Coated Balloon (DCB)

Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm

DEVICE

PTA Balloon: Balloon Angioplasty

Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm

Sponsors & Collaborators

  • Medtronic Endovascular

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2014-02-28
Completion
2018-05-31

Countries

  • United States

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 NCT01566461 on ClinicalTrials.gov