Trials / Completed
CompletedNCT01366482
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 121 (actual)
- Sponsor
- Medtronic Endovascular · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cotavance Drug-Eluting Balloon | Treatment with a paclitaxel-coated angioplasty balloon (without preceding plaque excision) |
| 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 |
| DEVICE | TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon | Plaque excision followed by treatment with a paclitaxel-coated angioplasty balloon |
Timeline
- Start date
- 2011-07-01
- Primary completion
- 2014-05-01
- Completion
- 2014-05-01
- First posted
- 2011-06-06
- Last updated
- 2019-05-29
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT01366482. Inclusion in this directory is not an endorsement.