Clinical trial
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).
NCT01221610 is registered in ClinicalTrials.gov with Biotronik AG as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- 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).
- Lead sponsor
- Biotronik AG
- Phase
- Not applicable
- Overall status
- Completed
- Start date
- October 31, 2010
- Completion date
- January 31, 2013
- Enrollment
- 60 (actual)
- Sites
- 5
Conditions
As the registry lists them; a condition with its own page is linked.
arteriosclerosis, atherosclerosis, peripheral artery disease, vascular disease