Atherectomy Followed by a Drug Coated Balloon to Treat Peripheral Arterial Disease (DEFINITIVE AR)

Medtronic

Status: Completed

Conditions: Claudication; Peripheral Arterial Disease

Treatments: Device: Cotavance Drug-Eluting Balloon; Device: TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon

Study type: Interventional

Funder types: Industry

Identifiers

NCT01366482

P-4941

Details and patient eligibility

About

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.

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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121 participants in 3 patient groups

Drug-eluting balloon

Experimental group

Description:

Subjects are randomized to have a lesion treated with a paclitaxel-coated balloon Intervention: Cotavance Drug-Eluting Balloon

Treatment:

Device: Cotavance Drug-Eluting Balloon

Plaque excision + drug-eluting balloon

Experimental group

Description:

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

Treatment:

Device: TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon

Device: TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon

Severely Ca++ Group

Experimental group

Description:

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

Treatment:

Device: TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon

Device: TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon