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

Medtronic Endovascular121 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

121

Conditions

Peripheral Arterial Disease Claudication

Interventions

Cotavance Drug-Eluting BalloonDEVICE

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

TurboHawk/SilverHawk + Cotavance Drug-Eluting BalloonDEVICE

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

TurboHawk/SilverHawk + Cotavance Drug-Eluting BalloonDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Imelda Hospital

Bonheiden, Belgium

Outcomes

Primary Outcomes

Target Lesion Percent Stenosis

Time frame: 1 year

Data from ClinicalTrials.gov

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