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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Clinico 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 28, 2014

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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