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

Not Applicable

Completed

• Conditions: Claudication; Peripheral Arterial Disease
• Interventions: Device: Cotavance Drug-Eluting Balloon; Device: TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon

• Registration Number: NCT01366482
• Lead Sponsor: Medtronic Endovascular

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-02
• Study First Submitted QC: 2011-06-02
• Study First Posted: 2011-06-06
• Study Start: 2011-07
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-24
• Last Update Posted: 2019-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug-eluting balloon	Cotavance Drug-Eluting Balloon	Subjects are randomized to have a lesion treated with a paclitaxel-coated balloon Intervention: Cotavance Drug-Eluting Balloon
Severely Ca++ Group	TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon	Subjects with a severely calcified lesion will be assigned to a non-randomized arm and treated with plaque excision followed by a drug-eluting balloon Intervention: SilverHawk/TurboHawk + Cotavance Drug-Eluting Balloon
Plaque excision + drug-eluting balloon	TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon	Subjects are randomized to have a lesion treated with plaque excision (PE) followed by treatment with a paclitaxel-coated balloon Intervention: SilverHawk/TurboHawk + Cotavance Drug-Eluting Balloon

Primary Outcome Measures

Name	Time	Method
Target Lesion Percent Stenosis	1 year

Trial Locations

Locations (1)

Imelda Hospital; 🇧🇪 Bonheiden, Belgium