Retrospective Follow-up of BIOLUX P-I/-II

August 4, 2021 updated by: Biotronik AG

Retrospective 5-year Safety Analysis of the BIOLUX P-I and P-II Studies in Subjects Requiring Revascularization of Infrainguinal Arteries

The aim is to collect long-term clinical data from 132 patients from Belgium, Germany and Austria who had previously participated in either of the BIOLUX P-I or P-II studies. Patients in these studies were treated with either a percutaneous transluminal angioplasty (PTA) balloon catheter or a drug-coated Passe-18-Lux balloon (DCB). The purpose of Retro-BIOLUX P-I-II is to collect clinical data from patients treated with either Passeo-18 PTA or Passeo-18 Lux DCB to analyze the long-term effects.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

132

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

      • Graz, Austria
        • LKH Univ.-Klinikum Graz, Ambulanz für Angiologie
      • Vienna, Austria
        • Allgemeines Krankenhaus - Universitätsklinik für Radiodiagnostik, Klinische Abteilung für Kardiovaskuläre und Interventionelle Radiologie
      • Bonheiden, Belgium
        • Vascular Research Center Bornheiden, Imelda Hospital
      • Dendermonde, Belgium
        • A.Z. Sint-Blasius
      • Bad Krozingen, Germany
        • Clinic of Cardiology and Angiology II Bad Krozingen
      • Berlin, Germany
        • Gefäßzentrum am KEH
      • Leipzig, Germany
        • University Leipzig Medical Centre Medizinische Klinik und Poliklinik V (Angiologie)
      • Rosenheim, Germany
        • Institut für Diagnostische und Interventionelle Radiologie, RoMed Klinikum

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

No older than 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients from previous studies.

Description

Inclusion Criteria:

  1. Subject was previously enrolled in either BIOLUX P-I or BIOLUX P-II
  2. Subject was treated either with Passeo-18 PTA or Passeo-18 LUX
  3. Written informed consent by subject or subject's legal representative or impartial witness/waiver

Exclusion Criteria:

  1. Subject did neither participate in BIOLUX P-I nor BIOLUX P-II
  2. Subject was neither treated with Passeo-18 Lux nor with Passeo-18 PTA
  3. Subject is not willing to sign an informed consent /data release form

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Passeo 18 PTA
Previous treatment with uncoated Passeo 18 PTA balloon catheter
POBA
Passeo-18 Lux DCB
Previous teatment with Passeo-18 Lux DCB
DCB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 60 months
Overall survival at five years after index procedure, defined as death from any cause
60 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival, defined as the time in days after index procedure to date of death from any cause.
Time Frame: 60 months
60 months
Major amputations of target extremities
Time Frame: 60 months
60 months
Clinically-driven target lesion revascularization
Time Frame: 60 months
60 months
Cause of death (descriptive analysis) at five years after treatment within BIOLUX P-I/-II.
Time Frame: 60 months
60 months

Collaborators and Investigators

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

Sponsor

Investigators

  • Study Chair: Thomas Zeller, Prof Dr, Clinic of Cardiology and Angiology II Bad Krozingen

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)

February 25, 2020

Primary Completion (Actual)

June 5, 2021

Study Completion (Actual)

July 5, 2021

Study Registration Dates

First Submitted

January 30, 2020

First Submitted That Met QC Criteria

January 30, 2020

First Posted (Actual)

January 31, 2020

Study Record Updates

Last Update Posted (Actual)

August 5, 2021

Last Update Submitted That Met QC Criteria

August 4, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • C1901

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Overall Mortality

Clinical Trials on Passeo-18

3
Subscribe