Directional AthErectomy Followed by a PaclItaxel-Coated BallooN to InhibiT RestenosIs and Maintain Vessel PatEncy: A Pilot Study of Anti-Restenosis Treatment

Medtronic Endovascular1 site in 1 country121 target enrollmentJuly 2011

ConditionsPeripheral Arterial Disease Claudication

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Arterial Disease
Sponsor: Medtronic Endovascular
Enrollment: 121
Locations: 1
Primary Endpoint: Target Lesion Percent Stenosis
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 2011

End Date

May 2014

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medtronic Endovascular

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Rutherford Clinical Category 2-4
•At least 18 years of age
•Is able and willing to provide written informed consent prior to study specific procedures

Exclusion Criteria

•Has a life expectancy of less than 24 months
•Is pregnant, of childbearing potential not taking adequate contraceptive measures, or nursing
•Has one or more of the contraindications listed in the SilverHawk/ TurboHawk or Cotavance IFUs