Trials / Completed
CompletedNCT00934752
De Novo Pilot Study, Lutonix Catheter in Conjunction With Bare Metal Stenting for Treatment of Coronary De Novo Lesions
An Exploratory Study Investigating the Use of the Lutonix Paclitaxel-Coated Balloon in Conjunction With Bare Metal Stenting in Patients With De Novo Coronary Lesions.
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- C. R. Bard · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study will enroll patients with angiographically significant coronary de novo lesions. Subjects will be randomized 1:1 and treated with a Lutonix catheter either before or after bare-metal stenting (BMS). The purpose is to assess the feasibility, safety and efficacy of the Lutonix Catheter for treatment of de novo coronary artery stenosis using two distinct treatment strategies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Lutonix Paclitaxel-Coated Balloon | Percutaneous transluminal coronary angioplasty (PCTA) |
Timeline
- Start date
- 2009-07-01
- Primary completion
- 2010-04-01
- Completion
- 2012-01-01
- First posted
- 2009-07-08
- Last updated
- 2017-01-16
Locations
3 sites across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT00934752. Inclusion in this directory is not an endorsement.