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

NCT04250909 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 132

Last updated 2021-08-05

No results posted yet for this study

Summary

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.

Conditions

  • Overall Mortality

Interventions

DEVICE

Passeo-18

POBA

DEVICE

Passeo-18 Lux

DCB

Sponsors & Collaborators

  • Biotronik AG

    lead INDUSTRY

Principal Investigators

  • Thomas Zeller, Prof Dr · Clinic of Cardiology and Angiology II Bad Krozingen

Eligibility

Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-25
Primary Completion
2021-06-05
Completion
2021-07-05

Countries

  • Austria
  • Belgium
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04250909 on ClinicalTrials.gov