- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04250909
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
Intervention / Treatment
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
-
-
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Graz, Austria
- LKH Univ.-Klinikum Graz, Ambulanz für Angiologie
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Vienna, Austria
- Allgemeines Krankenhaus - Universitätsklinik für Radiodiagnostik, Klinische Abteilung für Kardiovaskuläre und Interventionelle Radiologie
-
-
-
-
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Bonheiden, Belgium
- Vascular Research Center Bornheiden, Imelda Hospital
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Dendermonde, Belgium
- A.Z. Sint-Blasius
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-
-
-
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Bad Krozingen, Germany
- Clinic of Cardiology and Angiology II Bad Krozingen
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Berlin, Germany
- Gefäßzentrum am KEH
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Leipzig, Germany
- University Leipzig Medical Centre Medizinische Klinik und Poliklinik V (Angiologie)
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Rosenheim, Germany
- Institut für Diagnostische und Interventionelle Radiologie, RoMed Klinikum
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-
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:
- Subject was previously enrolled in either BIOLUX P-I or BIOLUX P-II
- Subject was treated either with Passeo-18 PTA or Passeo-18 LUX
- Written informed consent by subject or subject's legal representative or impartial witness/waiver
Exclusion Criteria:
- Subject did neither participate in BIOLUX P-I nor BIOLUX P-II
- Subject was neither treated with Passeo-18 Lux nor with Passeo-18 PTA
- 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.
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