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OpenTrials
Completed

NCT Number: NCT04250909

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

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.

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Key information

Conditions

Overall Mortality

Age range

Up to 100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

LKH Univ.-Klinikum Graz, Ambulanz für Angiologie, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Passeo-18

Device

POBA

Passeo-18 Lux

Device

DCB

Primary outcomes

  1. Overall survival

    Time frame: 60 months

    Overall survival at five years after index procedure, defined as death from any cause

Secondary outcomes

  1. Overall survival, defined as the time in days after index procedure to date of death from any cause.

    Time frame: 60 months

  2. Major amputations of target extremities

    Time frame: 60 months

  3. Clinically-driven target lesion revascularization

    Time frame: 60 months

  4. Cause of death (descriptive analysis) at five years after treatment within BIOLUX P-I/-II.

    Time frame: 60 months

Sponsors and collaborators

Lead sponsor

Biotronik AG

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 31, 2020
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.