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AtherosclerosisNCT02276313

BIOLUX P-III All-Comers Passeo-18 Lux Registry

An observational study of Atherosclerosis and Peripheral Artery Disease, run by Biotronik AG at 45 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atherosclerosis, Peripheral Artery Disease
What is being tested?
Passeo-18 Lux
Type of treatment
Medical device
How many people
880 participants
Where
45 sitesin 16 countries
Study dates
Oct 2014to Jan 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Subjects from an all-comers patient population with all subjects requiring infrainguinal revascularization with the Passeo-18 Lux DRB.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

45 sites in 16 countries.

45 sites in 16 countries

Germany10 sites

  • Klinikum Arnsberg, Karolinenhospital

    Arnsberg, D-59759

  • Department of Angiology at Universitats- Herzzentrum Freiburg

    Bad Krozingen, 79189

  • Gemeinschaftspraxis für Radiologie

    Berlin, 13347

  • Sank Gertrauden-Krankenhaus

    Berlin

  • Universitätsklinikum Giessen und Marburg GmbH

    Giessen, 35392

  • Herz- und Gefässzentrum Göttingen

    Göttingen, 37073

  • Universitätsklinikum Jena

    Jena, 07747

  • Universitätsklinikum Schleswig-Holstein

    Kiel

  • Kliniken München Pasing-Perlach GmbH

    München Pasing

  • RoMed Klinikum Rosenheim

    Rosenheim, 83022

Other trials in Germany

Australia5 sites

  • Cairns Hospital

    Cairns

  • Lake Macquarie Private Hospital

    Gateshead

  • Geelong University Hospital

    Geelong

  • Hollywood Hospital

    Nedlands

  • The Townsville Hospital

    Townsville

Other trials in Australia

Belgium4 sites

  • UCL St. Luc

    Brussels

  • UZ Leuven

    Leuven

  • CHR de la Citadelle

    Liège

  • Regionaal Ziekenhuis Heilig Hart Tienen

    Tienen

Other trials in Belgium

France4 sites

  • CHU de Clermont-Ferrand

    Clermont-Ferrand

  • Clinique Pasteur Essey Les Nancy

    Essey-lès-Nancy

  • CHU de Grenoble

    Grenoble

  • Hospices Civils de Lyon

    Lyon

Other trials in France

Spain4 sites

  • Hospital. Universitario Germans Trias i Pujol

    Badalona

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

  • Hospital Clinico San Carlos

    Madrid

  • Hospital Universitario Severo Ochoa

    Madrid

Other trials in Spain

Singapore3 sites

  • Changi General Hospital

    Singapore

  • Singapore General Hospital

    Singapore

  • Tan Tock Seng Hospital

    Singapore

Other trials in Singapore

Switzerland3 sites

  • Centre Hopsitalier Universitaire Vaudois

    Lausanne

  • Ospedale Regionale di Lugano

    Lugano

  • KS Winterthur

    Winterthur

Other trials in Switzerland

Austria2 sites

  • Medizinische Universität Graz

    Graz, 8036

  • Department Radiologie, Universitätsklinik für Radiodiagnostik

    Innsbruck, A-6020

Other trials in Austria

Italy2 sites

  • Ospedale San Giovanni di Dio

    Florence

  • Policlinico San Donato

    San Donato Milanese

Other trials in Italy

Netherlands2 sites

  • Catharina Hospital

    Eindhoven

  • Saint Elisabeth Hospital

    Tilburg

Other trials in Netherlands

Denmark1 site

  • Kolding Hospital

    Kolding, 6000

Other trials in Denmark

Finland1 site

  • Tampereen Yliopiostollinen Keskussariaaia

    Tampere

Other trials in Finland

Latvia1 site

  • P.Stradins Clinical University Hospital, Institute of Diagnostic

    Riga, LV 1012

Other trials in Latvia

Malaysia1 site

  • Institute Jantung Negara

    Kuala Lumpur

Other trials in Malaysia

Portugal1 site

  • Hospital Garcia de Orta

    Almada

Other trials in Portugal

Slovakia1 site

  • Institute of Cardiovascular diseases Kosice, Dpt. of Angiology

    Košice

Other trials in Slovakia

About this study

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

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.

Read the 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.

Being tested
Passeo-18 Lux
Keywords
Peripheral, Infrainguinal, Drug Releasing Balloon, Drug Eluting Balloon
Medical subject headings
Atherosclerosis, Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Passeo-18 LuxDevice

    Endovascular Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

  2. Freedom from clinically-driven Target Lesion Revascularization (TLR)

    Measured: 12 months

Secondary outcomes (11)

  1. Freedom from clinically-driven TLR

    Measured: 6 and 24 months

  2. Freedom from clinically-driven Target Vessel Revascularization (TVR)

    Measured: 6 and 24 months

  3. Primary patency

    Measured: 12 and 24 months

  4. Freedom from MAE

    Measured: 12 and 24 months

  5. Change in mean Ankle Brachial Index

    Measured: 6, 12 and 24 months

  6. Amputation-free survival

    Measured: 6, 12 and 24 months

  7. Patient-reported outcomes assessment: Pain score, Walking Impairment Questionnaire

    Measured: 6, 12 and 24 months

  8. Clinical Success: Improvement in Rutherford classification compared to the pre-procedure Rutherford classification

    Measured: 6, 12 and 24 months

  9. Device success

    Successful delivery, inflation, deflation, and retrieval of the Passeo-18 Lux DRB.

    Measured: Day 0

  10. Technical success

    Successful completion of the endovascular procedure and immediate morphological success with ≤ 50% residual diameter reduction of the treated lesion as determined by visual estimation

    Measured: Day 0

  11. Procedural success

    Procedural success is technical and device success without the occurrence of any major adverse events during the hospital stay

    Measured: Participants will be followed for the duration of hospital stay, an expected average of 1-2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionApr 2018
  4. Study completionJan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
880 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02276313
Sponsor's protocol ID
C1211
Status last verified
Aug 2022
First submitted
22 Oct 2014
Last updated
15 Aug 2022
Results posted
No
Data monitoring committee
No

Publications

  • Dodd J, Stratford G, Brodmann M, Moscovic M, Wang JCC, Nano G, Zeller T, Christensen JK, Tepe G, Mwipatayi BP; BIOLUX P-III Global Registry; BIOLUX P-III Global Registry Investigators:; BIOLUX P-III Global Registry Investigators:. Five-Year Outcomes of Paclitaxel-Coated Balloons in Patients with Diabetes from the BIOLUX P-III Single-Arm Study. Vasc Health Risk Manag. 2026 Jun 30;22:595482. doi: 10.2147/VHRM.S595482. eCollection 2026.

    PubMed 42416524

  • 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.

    PubMed 39158589

  • 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.

    PubMed 35445317

  • 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.

    PubMed 33831519

  • 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.

    PubMed 33083853

  • 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.

    PubMed 32964317

  • 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.

    PubMed 31989855

Questions about this trial

What is this clinical trial studying?

An observational study of Atherosclerosis and Peripheral Artery Disease, run by Biotronik AG at 45 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in Germany, Australia, Belgium, France, Spain and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from Major Adverse Events (MAE) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02276313, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2022.

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