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

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

Recruiting
100 years and younger
All
Phase N/A

Overview

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.

Eligibility

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 details
    Overall Mortality

NCT04250909

Biotronik AG

16 February 2024

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