BIOLUX P-III All-Comers Passeo-18 Lux Registry
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
1 other identifier
observational
880
15 countries
43
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2014
Longer than P75 for all trials
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 22, 2014
CompletedFirst Posted
Study publicly available on registry
October 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedAugust 15, 2022
August 1, 2022
3.5 years
October 22, 2014
August 12, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Freedom from Major Adverse Events (MAE)
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.
6 months
Freedom from clinically-driven Target Lesion Revascularization (TLR)
12 months
Secondary Outcomes (11)
Freedom from clinically-driven TLR
6 and 24 months
Freedom from clinically-driven Target Vessel Revascularization (TVR)
6 and 24 months
Primary patency
12 and 24 months
Freedom from MAE
12 and 24 months
Change in mean Ankle Brachial Index
6, 12 and 24 months
- +6 more secondary outcomes
Interventions
Endovascular Therapy
Eligibility Criteria
Subjects from an all-comers patient population with all subjects requiring infrainguinal revascularization with the Passeo-18 Lux DRB.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biotronik AGlead
Study Sites (45)
Cairns Hospital
Cairns, Australia
Lake Macquarie Private Hospital
Gateshead, Australia
Geelong University Hospital
Geelong, Australia
Hollywood Hospital
Nedlands, Australia
The Townsville Hospital
Townsville, Australia
Medizinische Universität Graz
Graz, 8036, Austria
Department Radiologie, Universitätsklinik für Radiodiagnostik
Innsbruck, A-6020, Austria
UCL St. Luc
Brussels, Belgium
UZ Leuven
Leuven, Belgium
CHR de la Citadelle
Liège, Belgium
Regionaal Ziekenhuis Heilig Hart Tienen
Tienen, Belgium
Kolding Hospital
Kolding, 6000, Denmark
Tampereen Yliopiostollinen Keskussariaaia
Tampere, Finland
CHU de Clermont-Ferrand
Clermont-Ferrand, France
Clinique Pasteur Essey Les Nancy
Essey-lès-Nancy, France
CHU de Grenoble
Grenoble, France
Hospices Civils de Lyon
Lyon, France
Klinikum Arnsberg, Karolinenhospital
Arnsberg, D-59759, Germany
Department of Angiology at Universitats- Herzzentrum Freiburg
Bad Krozingen, 79189, Germany
Gemeinschaftspraxis für Radiologie
Berlin, 13347, Germany
Sank Gertrauden-Krankenhaus
Berlin, Germany
Universitätsklinikum Giessen und Marburg GmbH
Giessen, 35392, Germany
Herz- und Gefässzentrum Göttingen
Göttingen, 37073, Germany
Universitätsklinikum Jena
Jena, 07747, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, Germany
Kliniken München Pasing-Perlach GmbH
München Pasing, Germany
RoMed Klinikum Rosenheim
Rosenheim, 83022, Germany
Ospedale San Giovanni di Dio
Florence, Italy
Policlinico San Donato
San Donato Milanese, Italy
P.Stradins Clinical University Hospital, Institute of Diagnostic
Riga, LV 1012, Latvia
Institute Jantung Negara
Kuala Lumpur, Malaysia
Catharina Hospital
Eindhoven, Netherlands
Saint Elisabeth Hospital
Tilburg, Netherlands
Hospital Garcia de Orta
Almada, Portugal
Changi General Hospital
Singapore, Singapore
Singapore General Hospital
Singapore, Singapore
Tan Tock Seng Hospital
Singapore, Singapore
Institute of Cardiovascular diseases Kosice, Dpt. of Angiology
Košice, Slovakia
Hospital. Universitario Germans Trias i Pujol
Badalona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Universitario Severo Ochoa
Madrid, Spain
Centre Hopsitalier Universitaire Vaudois
Lausanne, Switzerland
Ospedale Regionale di Lugano
Lugano, Switzerland
KS Winterthur
Winterthur, Switzerland
Related Publications (6)
Dodd JE, Hanna J, Brodmann M, Golledge J, Zeller T, Moscovic M, Dahm J, Troisi N, Tepe G, Wong J, Ward NC, Mwipatayi BP. Outcomes of drug-coated balloon angioplasty in patients with dyslipidemia in the BIOLUX P-III registry: A subgroup analysis. Vascular. 2025 Dec;33(6):1288-1303. doi: 10.1177/17085381241275795. Epub 2024 Aug 19.
PMID: 39158589DERIVEDBarry IP, Macarulay R, Brodmann M, Zeller T, Moscovic M, Dahm J, Troisi N, Tepe G, Wong J, Mwipatayi BP; BIOLUX P-III Global Registry Investigators. Sex-Related Outcomes Following Drug Balloon Angioplasty in Patients from the BIOLUX P-III Registry: A Subgroup Analysis. Cardiovasc Intervent Radiol. 2022 Jul;45(7):918-928. doi: 10.1007/s00270-022-03135-w. Epub 2022 Apr 20.
PMID: 35445317DERIVEDMwipatayi BP, Barry IP, Brodmann M, Zeller T, Varcoe RL, Moscovic M, Chian JWC, Christensen JK, Yahaya SA, Oshin OA, Tepe G; BIOLUX P-III Global Registry Investigators. Twenty-Four-Month Outcomes of Drug-Coated Balloon in Diabetic Patients in the BIOLUX P-III Registry: A Subgroup Analysis. Ann Vasc Surg. 2021 Aug;75:237-252. doi: 10.1016/j.avsg.2021.02.050. Epub 2021 Apr 5.
PMID: 33831519DERIVEDTepe G, Zeller T, Moscovic M, Corpataux JM, Christensen JK, Keirse K, Nano G, Schroeder H, Binkert CA, Brodmann M. Paclitaxel-Coated Balloon Angioplasty for the Treatment of Infrainguinal Arteries: 24-Month Outcomes in the Full Cohort of BIOLUX P-III Global Registry. Cardiovasc Intervent Radiol. 2021 Feb;44(2):207-217. doi: 10.1007/s00270-020-02663-7. Epub 2020 Oct 20.
PMID: 33083853DERIVEDTepe G, Wang J, Corpataux JM, Pua U, Binkert CA, Moscovic M, Ghotbi R, Keirse K, Robertson D, Brodmann M. BIOLUX P-III Passeo-18 Lux All-Comers Registry: 24-Month Results in Below-the-Knee Arteries. Cardiovasc Intervent Radiol. 2021 Jan;44(1):10-18. doi: 10.1007/s00270-020-02586-3. Epub 2020 Sep 22.
PMID: 32964317DERIVEDTepe G, Zeller T, Moscovic M, Corpataux JM, Christensen JK, Keirse K, Nano G, Schroeder H, Binkert CA, Brodmann M. Paclitaxel-Coated Balloon for the Treatment of Infrainguinal Disease: 12-Month Outcomes in the All-Comers Cohort of BIOLUX P-III Global Registry. J Endovasc Ther. 2020 Apr;27(2):304-315. doi: 10.1177/1526602819898804. Epub 2020 Jan 28.
PMID: 31989855DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gunnar Tepe, MD
RoMed Klinikum Rosenheim
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2014
First Posted
October 28, 2014
Study Start
October 1, 2014
Primary Completion
April 1, 2018
Study Completion
January 1, 2022
Last Updated
August 15, 2022
Record last verified: 2022-08