Trials / Completed
CompletedNCT01330628
Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis
EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 252 (actual)
- Sponsor
- Spectranetics Corporation · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the safety and efficacy of laser atherectomy with balloon angioplasty compared to balloon angioplasty alone in the treatment of above the knee peripheral artery in-stent restenosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Turbo Elite Laser and Turbo Tandem Laser Guide Catheters | application of laser energy to remove blockage followed by standard balloon angioplasty |
| PROCEDURE | Balloon angioplasty | standard balloon catheters for PTA |
Timeline
- Start date
- 2011-06-01
- Primary completion
- 2014-03-01
- Completion
- 2015-05-01
- First posted
- 2011-04-07
- Last updated
- 2016-08-18
- Results posted
- 2016-06-15
Locations
34 sites across 2 countries: United States, Puerto Rico
Source: ClinicalTrials.gov record NCT01330628. Inclusion in this directory is not an endorsement.