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

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

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.

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