Trials / Completed
CompletedNCT01864278
Lutonix Global SFA Registry
A Prospective, Global Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the LUTONIX Drug Coated PTA Dilatation Catheter
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 691 (actual)
- Sponsor
- C. R. Bard · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The registry will enroll patients with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery. Subjects will be treated with the LUTONIX Drug Coated PTA Dilatation Catheter carrying the CE Mark per current Instructions for Use(IFU) and followed clinically for a minimum of 2 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Lutonix Drug Coated Balloon | Subject will receive treatment with the Lutonix Drug Coated Balloon |
Timeline
- Start date
- 2012-12-01
- Primary completion
- 2015-07-01
- Completion
- 2016-09-01
- First posted
- 2013-05-29
- Last updated
- 2016-11-08
Locations
23 sites across 10 countries: Austria, Belgium, France, Germany, Greece, Italy, Poland, Spain, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT01864278. Inclusion in this directory is not an endorsement.