BIOLUX P-III All-Comers Passeo-18 Lux Registry
|ClinicalTrials.gov Identifier: NCT02276313|
Recruitment Status : Unknown
Verified May 2018 by Biotronik AG.
Recruitment status was: Active, not recruiting
First Posted : October 28, 2014
Last Update Posted : May 31, 2018
|Condition or disease||Intervention/treatment|
|Atherosclerosis Peripheral Artery Disease||Device: Passeo-18 Lux|
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.
|Study Type :||Observational|
|Actual Enrollment :||880 participants|
|Official Title:||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|
|Actual Study Start Date :||October 2014|
|Actual Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||February 2019|
- Device: Passeo-18 Lux
- Freedom from Major Adverse Events (MAE) [ Time Frame: 6 months ]A composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and clinically driven target lesion revascularization (TLR) within 6 months post-index procedure.
- Freedom from clinically-driven Target Lesion Revascularization (TLR) [ Time Frame: 12 months ]
- Freedom from clinically-driven TLR [ Time Frame: 6 and 24 months ]
- Freedom from clinically-driven Target Vessel Revascularization (TVR) [ Time Frame: 6 and 24 months ]
- Primary patency [ Time Frame: 12 and 24 months ]
- Freedom from MAE [ Time Frame: 12 and 24 months ]
- Change in mean Ankle Brachial Index [ Time Frame: 6, 12 and 24 months ]
- Amputation-free survival [ Time Frame: 6, 12 and 24 months ]
- Patient-reported outcomes assessment: Pain score, Walking Impairment Questionnaire [ Time Frame: 6, 12 and 24 months ]
- Clinical Success: Improvement in Rutherford classification compared to the pre-procedure Rutherford classification [ Time Frame: 6, 12 and 24 months ]
- Device success [ Time Frame: Day 0 ]Successful delivery, inflation, deflation, and retrieval of the Passeo-18 Lux DRB.
- Technical success [ Time Frame: Day 0 ]Successful completion of the endovascular procedure and immediate morphological success with ≤ 50% residual diameter reduction of the treated lesion as determined by visual estimation
- Procedural success [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1-2 days ]Procedural success is technical and device success without the occurrence of any major adverse events during the hospital stay
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276313
|Principal Investigator:||Gunnar Tepe, MD||RoMed Klinikum Rosenheim|