Trials / Completed
CompletedNCT01867736
BIOLUX P-II First-in-Man Study to Compare the Passeo-18 Lux DRB Against POBA in Infrapopliteal Arteries
BIOTRONIK's - First in Men Study of the Passeo-18 LUX Drug Releasing PTA Balloon Catheter vs. the Uncoated Passeo 18 Balloon Catheter in Subjects Requiring Revascularization of Infrapopliteal Arteries (BIOLUX P-II).
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- Biotronik AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A prospective, multicentric, randomized controlled trial to assess the safety and performance of the Passeo-18 Lux Paclitaxel releasing PTA balloon catheter versus the uncoated Passeo 18 PTA balloon catheter for the treatment of stenosis, restenosis or occlusion of the infrapopliteal arteries.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Passeo-18 Lux DRB | |
| DEVICE | Standard PTA (POBA) |
Timeline
- Start date
- 2012-07-01
- Primary completion
- 2014-01-01
- Completion
- 2014-07-01
- First posted
- 2013-06-04
- Last updated
- 2015-02-09
Locations
6 sites across 3 countries: Austria, Belgium, Germany
Source: ClinicalTrials.gov record NCT01867736. Inclusion in this directory is not an endorsement.