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

August 12, 2022 updated by: Biotronik AG

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

880

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Cairns, Australia
        • Cairns Hospital
      • Gateshead, Australia
        • Lake Macquarie Private Hospital
      • Geelong, Australia
        • Geelong University Hospital
      • Nedlands, Australia
        • Hollywood Hospital
      • Townsville, Australia
        • The Townsville Hospital
  • Austria
      • Graz, Austria, 8036
        • Medizinische Universität Graz
      • Innsbruck, Austria, A-6020
        • Department Radiologie, Universitätsklinik für Radiodiagnostik
  • Belgium
      • Brussels, Belgium
        • UCL St. Luc
      • Leuven, Belgium
        • UZ Leuven
      • Liege, Belgium
        • Chr de La Citadelle
      • Tienen, Belgium
        • Regionaal Ziekenhuis Heilig Hart Tienen
  • Denmark
      • Kolding, Denmark, 6000
        • Kolding Hospital
  • Finland
      • Tampere, Finland
        • Tampereen Yliopiostollinen Keskussariaaia
  • France
      • Clermont-Ferrand, France
        • CHU de Clermont-Ferrand
      • Essey Les Nancy, France
        • Clinique Pasteur Essey Les Nancy
      • Grenoble, France
        • CHU de GRENOBLE
      • Lyon, France
        • Hospices Civils de LYON
  • Germany
      • Arnsberg, Germany, D-59759
        • Klinikum Arnsberg, Karolinenhospital
      • Bad Krozingen, Germany, 79189
        • Department of Angiology at Universitats- Herzzentrum Freiburg
      • Berlin, Germany, 13347
        • Gemeinschaftspraxis für Radiologie
      • Berlin, Germany
        • Sank Gertrauden-Krankenhaus
      • Giessen, Germany, 35392
        • Universitätsklinikum Gießen und Marburg GmbH
      • Göttingen, Germany, 37073
        • Herz- und Gefässzentrum Göttingen
      • Jena, Germany, 07747
        • Universitätsklinikum Jena
      • Kiel, Germany
        • Universitätsklinikum Schleswig-Holstein
      • München Pasing, Germany
        • Kliniken München Pasing-Perlach GmbH
      • Rosenheim, Germany, 83022
        • RoMed Klinikum Rosenheim
  • Italy
      • Firenze, Italy
        • Ospedale San Giovanni di Dio
      • San Donato Milanese, Italy
        • Policlinico San Donato
  • Latvia
      • Riga, Latvia, LV 1012
        • P.Stradins Clinical University Hospital, Institute of Diagnostic
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Institute Jantung Negara
  • Netherlands
      • Eindhoven, Netherlands
        • Catharina Hospital
      • Tilburg, Netherlands
        • Saint Elisabeth Hospital
  • Portugal
      • Almada, Portugal
        • Hospital Garcia de Orta
  • Singapore
      • Singapore, Singapore
        • Singapore General Hospital
      • Singapore, Singapore
        • Tan Tock Seng Hospital
      • Singapore, Singapore
        • Changi General Hospital
  • Slovakia
      • Kosice, Slovakia
        • Institute of Cardiovascular diseases Kosice, Dpt. of Angiology
  • Spain
      • Badalona, Spain
        • Hospital. Universitario Germans Trias i Pujol
      • Barcelona, Spain
        • Hospital de la Santa Creu i Sant Pau
      • Madrid, Spain
        • Hospital Clínico San Carlos
      • Madrid, Spain
        • Hospital Universitario Severo Ochoa
  • Switzerland
      • Lausanne, Switzerland
        • Centre hopsitalier universitaire Vaudois
      • Lugano, Switzerland
        • Ospedale Regionale di Lugano
      • Winterthur, Switzerland
        • KS Winterthur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from Major Adverse Events (MAE)
Time Frame: 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.
6 months
Freedom from clinically-driven Target Lesion Revascularization (TLR)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary patency
Time Frame: 12 and 24 months
12 and 24 months
Freedom from clinically-driven TLR
Time Frame: 6 and 24 months
6 and 24 months
Freedom from clinically-driven Target Vessel Revascularization (TVR)
Time Frame: 6 and 24 months
6 and 24 months
Freedom from MAE
Time Frame: 12 and 24 months
12 and 24 months
Change in mean Ankle Brachial Index
Time Frame: 6, 12 and 24 months
6, 12 and 24 months
Amputation-free survival
Time Frame: 6, 12 and 24 months
6, 12 and 24 months
Patient-reported outcomes assessment: Pain score, Walking Impairment Questionnaire
Time Frame: 6, 12 and 24 months
6, 12 and 24 months
Clinical Success: Improvement in Rutherford classification compared to the pre-procedure Rutherford classification
Time Frame: 6, 12 and 24 months
6, 12 and 24 months
Device success
Time Frame: Day 0
Successful delivery, inflation, deflation, and retrieval of the Passeo-18 Lux DRB.
Day 0
Technical success
Time Frame: 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
Day 0
Procedural success
Time Frame: 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
Participants will be followed for the duration of hospital stay, an expected average of 1-2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2014

Primary Completion (ACTUAL)

April 1, 2018

Study Completion (ACTUAL)

January 1, 2022

Study Registration Dates

First Submitted

October 22, 2014

First Submitted That Met QC Criteria

October 24, 2014

First Posted (ESTIMATE)

October 28, 2014

Study Record Updates

Last Update Posted (ACTUAL)

August 15, 2022

Last Update Submitted That Met QC Criteria

August 12, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C1211

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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