Claudication, Peripheral Arterial Disease
Conditions
Keywords
Peripheral arterial disease,, claudication,, atherectomy,, plaque excision,, drug-coated balloon, drug-eluting balloon
Brief summary
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.
Interventions
DEVICECotavance Drug-Eluting Balloon
Treatment with a paclitaxel-coated angioplasty balloon (without preceding plaque excision)
DEVICETurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon
Plaque excision with a SilverHawk or TurboHawk plaque excision device followed by treatment with a paclitaxel-coated angioplasty balloon
Sponsors
MEDRAD, Inc.
Medtronic Endovascular
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target Lesion Percent Stenosis | 1 year |
Countries
Belgium
Outcome results
None listed