BIOLUX P-III All-Comers Passeo-18 Lux Registry
- Conditions
- AtherosclerosisPeripheral Artery Disease
- Registration Number
- NCT02276313
- Lead Sponsor
- Biotronik AG
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 880
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Freedom from Major Adverse Events (MAE) 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) 12 months
- Secondary Outcome Measures
Name Time Method Change in mean Ankle Brachial Index 6, 12 and 24 months Freedom from clinically-driven TLR 6 and 24 months Freedom from MAE 12 and 24 months Patient-reported outcomes assessment: Pain score, Walking Impairment Questionnaire 6, 12 and 24 months Clinical Success: Improvement in Rutherford classification compared to the pre-procedure Rutherford classification 6, 12 and 24 months Technical success 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
Freedom from clinically-driven Target Vessel Revascularization (TVR) 6 and 24 months Primary patency 12 and 24 months Amputation-free survival 6, 12 and 24 months Device success Day 0 Successful delivery, inflation, deflation, and retrieval of the Passeo-18 Lux DRB.
Procedural success 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
Trial Locations
- Locations (45)
P.Stradins Clinical University Hospital, Institute of Diagnostic
🇱🇻Riga, Latvia
Regionaal Ziekenhuis Heilig Hart Tienen
🇧🇪Tienen, Belgium
Tampereen Yliopiostollinen Keskussariaaia
🇫🇮Tampere, Finland
Centre Hopsitalier Universitaire Vaudois
🇨🇭Lausanne, Switzerland
Kolding Hospital
🇩🇰Kolding, Denmark
Hospital Garcia de Orta
🇵🇹Almada, Portugal
Saint Elisabeth Hospital
🇳🇱Tilburg, Netherlands
Herz- und Gefässzentrum Göttingen
🇩🇪Göttingen, Germany
Lake Macquarie Private Hospital
🇦🇺Gateshead, Australia
Cairns Hospital
🇦🇺Cairns, Australia
Geelong University Hospital
🇦🇺Geelong, Australia
Hollywood Hospital
🇦🇺Nedlands, Australia
The Townsville Hospital
🇦🇺Townsville, Australia
Medizinische Universität Graz
🇦🇹Graz, Austria
Department Radiologie, Universitätsklinik für Radiodiagnostik
🇦🇹Innsbruck, Austria
UCL St. Luc
🇧🇪Brussels, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
CHR de la Citadelle
🇧🇪Liege, Belgium
CHU de Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
Clinique Pasteur Essey Les Nancy
🇫🇷Essey Les Nancy, France
CHU de Grenoble
🇫🇷Grenoble, France
Hospices Civils de Lyon
🇫🇷Lyon, France
Klinikum Arnsberg, Karolinenhospital
🇩🇪Arnsberg, Germany
Universitätsklinikum Giessen und Marburg GmbH
🇩🇪Giessen, Germany
Department of Angiology at Universitats- Herzzentrum Freiburg
🇩🇪Bad Krozingen, Germany
Sank Gertrauden-Krankenhaus
🇩🇪Berlin, Germany
Gemeinschaftspraxis für Radiologie
🇩🇪Berlin, Germany
Kliniken München Pasing-Perlach GmbH
🇩🇪München Pasing, Germany
Universitätsklinikum Jena
🇩🇪Jena, Germany
Universitätsklinikum Schleswig-Holstein
🇩🇪Kiel, Germany
RoMed Klinikum Rosenheim
🇩🇪Rosenheim, Germany
Ospedale San Giovanni di Dio
🇮🇹Firenze, Italy
Policlinico San Donato
🇮🇹San Donato Milanese, Italy
Catharina Hospital
🇳🇱Eindhoven, Netherlands
Institute Jantung Negara
🇲🇾Kuala Lumpur, Malaysia
Changi General Hospital
🇸🇬Singapore, Singapore
Tan Tock Seng Hospital
🇸🇬Singapore, Singapore
Institute of Cardiovascular diseases Kosice, Dpt. of Angiology
🇸🇰Kosice, Slovakia
Singapore General Hospital
🇸🇬Singapore, Singapore
Hospital. Universitario Germans Trias i Pujol
🇪🇸Badalona, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitario Severo Ochoa
🇪🇸Madrid, Spain
KS Winterthur
🇨🇭Winterthur, Switzerland
Ospedale Regionale di Lugano
🇨🇭Lugano, Switzerland