BIOLUX P-III All-Comers Passeo-18 Lux Registry
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276313
|Principal Investigator:||Gunnar Tepe, MD||RoMed Klinikum Rosenheim|