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).

Biotronik AG5 sites in 2 countries60 target enrollmentOctober 2010

ConditionsAtherosclerosis Arteriosclerosis Vascular Disease Peripheral Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atherosclerosis
Sponsor: Biotronik AG
Enrollment: 60
Locations: 5
Primary Endpoint: Assessment of the 6 months late lumen loss in the target lesion measured by quantitative vascular angiography (QVA).
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 2010

End Date

January 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Biotronik AG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 50 years,
•Informed consent signed by patient prior to randomization
•Single or sequential de novo or restenotic lesions (stenosis ≥ 70% diameter reduction or occlusion) in the femoropopliteal arteries ≥ 30 mm and ≤ 200 mm long
•Rutherford Class 2 - 5 in the target limb
•Reference Vessel Diameter (RVD) 3 - 7 mm, based on visual estimation
•Inflow free from flow-limiting lesion (\< 50% stenosis) confirmed by angiography. Patients with flow-limiting inflow lesions (\> 50% stenosis) can be included if lesion has been treated successfully before the index procedure
•At least one non-occluded crural vessel (eg without significant stenosis) with angiographically documented run-off to the foot
•Successful wire crossing of the lesion
•Willingness to comply with all specified follow-up evaluations
•Male or negative pregnancy test of women in childbearing age

Exclusion Criteria

•Co-morbid conditions limiting life expectancy ≤ 1 year
•Patient currently participating in another clinical trial
•Lesions which are untreatable with PTA or other interventional techniques
•The target stenosis is located distal to a stenosis ≥ 50% that cannot be pre-treated because the drug coating could get lost during crossing the proximal lesion
•Thrombus in the target vessel, documented by angiography
•Target lesion is severely calcified, documented by angiography
•Prior bypass surgery of target vessel
•Previously implanted stent in the target lesion
•Treatment of bifurcation required
•Planned amputation of the target limb

Outcomes

Primary Outcomes

Assessment of the 6 months late lumen loss in the target lesion measured by quantitative vascular angiography (QVA).

Time Frame: 6 months

Secondary Outcomes

6 months and 12 months TLR rate(6 and 12 months)
6 months and 12 months change in Rutherford class(6 and 12 months)
Major Adverse Event rate at 6 and 12 months (procedure- or device-related death or amputation, target lesion thrombosis and clinically driven TLR)(6 and 12 months)
6 months binary restenosis rate(6 months)
6 months and 12 months change in mean ABI(6 and 12 months)