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

Study Overview
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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.

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

Conditions
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Claudication, Peripheral Arterial Disease

Intervention / Treatment
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* Device: Cotavance Drug-Eluting Balloon
* Device: TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon
* Device: TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug-eluting balloon<br>Subjects are randomized to have a lesion treated with a paclitaxel-coated balloon Intervention: Cotavance Drug-Eluting Balloon | Device: Cotavance Drug-Eluting Balloon<br>* Treatment with a paclitaxel-coated angioplasty balloon (without preceding plaque excision)<br>|
| Experimental: Plaque excision + drug-eluting balloon<br>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 | Device: TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon<br>* Plaque excision with a SilverHawk or TurboHawk plaque excision device followed by treatment with a paclitaxel-coated angioplasty balloon<br>|
| Experimental: Severely Ca++ Group<br>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 | Device: TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon<br>* Plaque excision followed by treatment with a paclitaxel-coated angioplasty balloon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Percent Stenosis |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral arterial disease,, claudication,, atherectomy,, plaque excision,, drug-coated balloon, drug-eluting balloon