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Randomized Trial of IN.PACT Admiral® Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease

NCT01175850 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 331

Last updated 2017-05-16

Study results available
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Summary

The objective of this Study is to evaluate the safety and efficacy of the IN.PACT Admiral® drug coated PTA balloon, utilized for the dilatation of the narrowed sections of the artery, as compared to other standard (non drug coated) PTA balloons. The IN.PACT Admiral, besides the mechanical dilatation effect typical of all PTA balloons, releases a drug (paclitaxel) from the balloon surface into the vessel walls. This drug absorption is intended to limit the chances and the entity of artery re-narrowing over time.

Conditions

  • Peripheral Arterial Disease (PAD)

Interventions

DEVICE

Drug-Coated Balloon (DCB)

balloon dilatation and provisional stenting with IN.PACT DCB

DEVICE

PTA Balloon: Balloon Angioplasty

balloon dilatation and provisional stenting with standard non-coated PTA balloon

Sponsors & Collaborators

  • Medtronic Endovascular

    lead INDUSTRY

Principal Investigators

  • Gunnar Tepe, Prof Dr. Med · Klinikum Rosenheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2014-02-28
Completion
2017-04-30

Countries

  • Germany

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 NCT01175850 on ClinicalTrials.gov