Status:
COMPLETED
BIOLUX P-III All-Comers Passeo-18 Lux Registry
Lead Sponsor:
Biotronik AG
Conditions:
Atherosclerosis
Peripheral Artery Disease
Eligibility:
All Genders
18+ years
Brief 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 treatm...
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...
Eligibility Criteria
Inclusion
- Age ≥ 18 years or minimum age as required by local regulations
- Subject must be willing to sign a Patient Data Release Form or Patient Informed Consent where applicable
- Lesion(s) in the infrainguinal arteries suitable for endovascular treatment treated with or scheduled to be treated with the Passeo-18 Lux drug releasing balloon
Exclusion
- Life expectancy ≤ 1 year
- Subject is currently participating in another investigational drug or device study that has not reached ist primary endpoint yet
- Subject is pregnant or planning to become pregnant during the course of the study
- Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
880 Patients enrolled
Trial Details
Trial ID
NCT02276313
Start Date
October 1 2014
End Date
January 1 2022
Last Update
August 15 2022
Active Locations (45)
Enter a location and click search to find clinical trials sorted by distance.
1
Cairns Hospital
Cairns, Australia
2
Lake Macquarie Private Hospital
Gateshead, Australia
3
Geelong University Hospital
Geelong, Australia
4
Hollywood Hospital
Nedlands, Australia