Clinical trial NCT02276313: BIOLUX P-III All-Comers Passeo-18 Lux Registry
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Peripheral Artery Disease
Keywords: Peripheral
Infrainguinal
Drug Releasing Balloon
Drug Eluting Balloon
Lead sponsor: Biotronik AG
Sponsor class: INDUSTRY
First posted: 2014-10-28
Enrollment: 880
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects from an all-comers patient population with all subjects requiring infrainguinal revascularization with the Passeo-18 Lux DRB.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Freedom from Major Adverse Events (MAE)
timeFrame: 6 months
measure: Freedom from clinically-driven Target Lesion Revascularization (TLR)
timeFrame: 12 months
Secondary outcomes:
measure: Freedom from clinically-driven TLR
timeFrame: 6 and 24 months
measure: Freedom from clinically-driven Target Vessel Revascularization (TVR)
timeFrame: 6 and 24 months
measure: Primary patency
timeFrame: 12 and 24 months
measure: Freedom from MAE
timeFrame: 12 and 24 months
measure: Change in mean Ankle Brachial Index
timeFrame: 6, 12 and 24 months
measure: Amputation-free survival
timeFrame: 6, 12 and 24 months
measure: Patient-reported outcomes assessment: Pain score, Walking Impairment Questionnaire
timeFrame: 6, 12 and 24 months
measure: Clinical Success: Improvement in Rutherford classification compared to the pre-procedure Rutherford classification
timeFrame: 6, 12 and 24 months
measure: Device success
timeFrame: Day 0
measure: Technical success
timeFrame: Day 0
measure: Procedural success
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1-2 days
Other outcomes:
Locations:
city: Cairns
country: Australia
facility: Cairns Hospital
city: Gateshead
country: Australia
facility: Lake Macquarie Private Hospital
city: Geelong
country: Australia
facility: Geelong University Hospital
city: Nedlands
country: Australia
facility: Hollywood Hospital
city: Townsville
country: Australia
facility: The Townsville Hospital
city: Graz
country: Austria
facility: Medizinische Universität Graz
city: Innsbruck
country: Austria
facility: Department Radiologie, Universitätsklinik für Radiodiagnostik
city: Brussels
country: Belgium
facility: UCL St. Luc
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liege
country: Belgium
facility: CHR de la Citadelle
city: Tienen
country: Belgium
facility: Regionaal Ziekenhuis Heilig Hart Tienen
city: Kolding
country: Denmark
facility: Kolding Hospital
city: Tampere
country: Finland
facility: Tampereen Yliopiostollinen Keskussariaaia
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Essey Les Nancy
country: France
facility: Clinique Pasteur Essey Les Nancy
city: Grenoble
country: France
facility: CHU de Grenoble
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Arnsberg
country: Germany
facility: Klinikum Arnsberg, Karolinenhospital
city: Bad Krozingen
country: Germany
facility: Department of Angiology at Universitats- Herzzentrum Freiburg
city: Berlin
country: Germany
facility: Gemeinschaftspraxis für Radiologie
city: Berlin
country: Germany
facility: Sank Gertrauden-Krankenhaus
city: Giessen
country: Germany
facility: Universitätsklinikum Giessen und Marburg GmbH
city: Göttingen
country: Germany
facility: Herz- und Gefässzentrum Göttingen
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: München Pasing
country: Germany
facility: Kliniken München Pasing-Perlach GmbH
city: Rosenheim
country: Germany
facility: RoMed Klinikum Rosenheim
city: Firenze
country: Italy
facility: Ospedale San Giovanni di Dio
city: San Donato Milanese
country: Italy
facility: Policlinico San Donato
city: Riga
country: Latvia
facility: P.Stradins Clinical University Hospital, Institute of Diagnostic
city: Kuala Lumpur
country: Malaysia
facility: Institute Jantung Negara
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
city: Tilburg
country: Netherlands
facility: Saint Elisabeth Hospital
city: Almada
country: Portugal
facility: Hospital Garcia de Orta
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Kosice
country: Slovakia
facility: Institute of Cardiovascular diseases Kosice, Dpt. of Angiology
city: Badalona
country: Spain
facility: Hospital. Universitario Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Severo Ochoa
city: Lausanne
country: Switzerland
facility: Centre Hopsitalier Universitaire Vaudois
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano
city: Winterthur
country: Switzerland
facility: KS Winterthur
Study officials:
affiliation: RoMed Klinikum Rosenheim
name: Gunnar Tepe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.