Trials / Completed
CompletedNCT02276313
BIOLUX P-III All-Comers Passeo-18 Lux Registry
BIOTRONIK - A Prospective, International, Mulit-centre, Post-market All-comers Registry to Assess the Clinical Performance of the Passeo-18 Lux Paclitaxel Releasing Balloon Catheter in Infrainguinal Arteries - III
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 880 (actual)
- Sponsor
- Biotronik AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
BIOLUX P-III is a prospective, international, multi-centre, postmarket all-comers registry to collect clinical performance data on the Passeo-18 Lux paclitaxel releasing balloon catheter in the treatment of atherosclerotic disease of the infrainguinal arteries.
Detailed description
The Passeo-18 LUX Paclitaxel Releasing BalloonCatheter is a novel drug-releasing balloon that received CE-mark in January 2014. Its safety and efficacy has been investigated in two randomized First-in-Man trials in patients with stenosis or occlusion of the femoropopliteal (BIOLUX P-I) and infrapopliteal (BIOLUX P-II) arteries when compared to an uncoated device. The purpose of the BIOLUX P-III all-comers registry is to collect short and long-term clinical performance data on the Passeo-18 Lux DRB in the treatment of atherosclerotic disease in the infrainguinal arteries in an all-comers patient population in daily clinical practice.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Passeo-18 Lux | Endovascular Therapy |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2018-04-01
- Completion
- 2022-01-01
- First posted
- 2014-10-28
- Last updated
- 2022-08-15
Locations
45 sites across 16 countries: Australia, Austria, Belgium, Denmark, Finland, France, Germany, Italy, Latvia, Malaysia, Netherlands, Portugal, Singapore, Slovakia, Spain, Switzerland
Source: ClinicalTrials.gov record NCT02276313. Inclusion in this directory is not an endorsement.