MedTrace Logo

Atherectomy Followed by a Drug Coated Balloon to Treat Peripheral Arterial Disease

NCT01366482 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2019-05-29

No results posted yet for this study

Summary

The DEFINITIVE AR study is a prospective, multi-center, randomized pilot study evaluating the use of either the TurboHawk™ or SilverHawk® plaque excision systems followed by treatment with the Cotavance™ drug-eluting balloon catheter versus the Cotavance balloon catheter alone in patients with peripheral arterial disease.

Conditions

  • Peripheral Arterial Disease
  • Claudication

Interventions

DEVICE

Cotavance Drug-Eluting Balloon

Treatment with a paclitaxel-coated angioplasty balloon (without preceding plaque excision)

DEVICE

TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon

Plaque excision with a SilverHawk or TurboHawk plaque excision device followed by treatment with a paclitaxel-coated angioplasty balloon

DEVICE

TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon

Plaque excision followed by treatment with a paclitaxel-coated angioplasty balloon

Sponsors & Collaborators

  • MEDRAD, Inc.

    collaborator INDUSTRY

  • Medtronic Endovascular

    lead INDUSTRY

Principal Investigators

  • Professor Thomas Zeller · Herz-Zentrum Bad Krozingen Germany

  • Professor Gunnar Tepe · Klinikum Rosenheim Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • Belgium

Study Locations

More Related Trials

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 NCT01366482 on ClinicalTrials.gov