Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
880 participants
OBSERVATIONAL
2014-10-31
2022-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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Passeo-18 Lux
Endovascular Therapy
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Biotronik AG
INDUSTRY
Responsible Party
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Principal Investigators
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Gunnar Tepe, MD
Role: PRINCIPAL_INVESTIGATOR
RoMed Klinikum Rosenheim
Locations
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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, , Austria
Department Radiologie, Universitätsklinik für Radiodiagnostik
Innsbruck, , 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, , 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, , Germany
Department of Angiology at Universitats- Herzzentrum Freiburg
Bad Krozingen, , Germany
Gemeinschaftspraxis für Radiologie
Berlin, , Germany
Sank Gertrauden-Krankenhaus
Berlin, , Germany
Universitätsklinikum Giessen und Marburg GmbH
Giessen, , Germany
Herz- und Gefässzentrum Göttingen
Göttingen, , Germany
Universitätsklinikum Jena
Jena, , Germany
Universitätsklinikum Schleswig-Holstein
Kiel, , Germany
Kliniken München Pasing-Perlach GmbH
München Pasing, , Germany
RoMed Klinikum Rosenheim
Rosenheim, , Germany
Ospedale San Giovanni di Dio
Florence, , Italy
Policlinico San Donato
San Donato Milanese, , Italy
P.Stradins Clinical University Hospital, Institute of Diagnostic
Riga, , 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
Countries
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References
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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. 2024 Aug 19:17085381241275795. doi: 10.1177/17085381241275795. Online ahead of print.
Barry 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.
Mwipatayi 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.
Tepe 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.
Tepe 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.
Tepe 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.
Other Identifiers
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C1211
Identifier Type: -
Identifier Source: org_study_id
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