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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2014-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Peripheral Arterial Disease Claudication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Drug-eluting balloon

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

Group Type EXPERIMENTAL

Cotavance Drug-Eluting Balloon

Intervention Type DEVICE

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

Plaque excision + 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

Group Type EXPERIMENTAL

TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon

Intervention Type DEVICE

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

Severely Ca++ Group

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

Group Type EXPERIMENTAL

TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon

Intervention Type DEVICE

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

Interventions

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Cotavance Drug-Eluting Balloon

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

Intervention Type 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

Intervention Type DEVICE

TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No