Trials / Completed
CompletedNCT01221610
BIOLUX P-I First in Man Study
A Prospective, Multi-centre, Randomized Controlled, First in Man Study to Assess the Safety and Performance of the Passeo-18 Lux Paclitaxel Releasing PTA Balloon Catheter vs. the Uncoated Passeo 18 Balloon Catheter in Patients With Stenosis and Occlusion of the Femoropopliteal Arteries (BIOLUX P-I).
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Biotronik AG · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
A prospective, multi-centre, randomized controlled, First in Man study to assess the safety and performance of the coated Passeo-18 Lux Paclitaxel releasing PTA Balloon Catheter vs. an uncoated balloon catheter in patients with stenosis and occlusion of the femoropopliteal arteries.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Passeo-18 Lux DRB | |
| DEVICE | Standard PTA (POBA) |
Timeline
- Start date
- 2010-10-01
- Primary completion
- 2012-02-01
- Completion
- 2013-01-01
- First posted
- 2010-10-15
- Last updated
- 2015-02-09
Locations
5 sites across 2 countries: Austria, Germany
Source: ClinicalTrials.gov record NCT01221610. Inclusion in this directory is not an endorsement.