Trials / Completed
CompletedNCT00916279
PERVIDEO I Registry, The Lutonix Paclitaxel-Coated Balloon Catheter for the Treatment of Coronary In-Stent Restenosis
A Prospective, Multicenter, European Registry Investigating the Lutonix Paclitaxel-Coated Balloon for the Treatment of In-Stent Restenosis Within Bare-Metal Stents
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- C. R. Bard · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study will enroll patients with angiographic evidence of in-stent restenosis of a previously placed bare-metal stent. Subjects will be treated with a Lutonix Catheter. The purpose is to investigate the feasibility, safety, and efficacy of the Lutonix Catheter in the native coronary system. Angiographic and clinical outcomes will be assessed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Lutonix Paclitaxel-Coated Balloon | PTCA |
Timeline
- Start date
- 2009-06-01
- Primary completion
- 2010-10-01
- Completion
- 2011-12-01
- First posted
- 2009-06-09
- Last updated
- 2017-02-27
- Results posted
- 2015-12-21
Locations
8 sites across 3 countries: Belgium, Germany, Netherlands
Source: ClinicalTrials.gov record NCT00916279. Inclusion in this directory is not an endorsement.