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

  • STATUS
    Recruiting
  • participants needed
    132
  • sponsor
    Biotronik AG
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Updated on 19 February 2024
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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.

Details
Condition Overall Mortality
Age 100years or below
Treatment Passeo-18, Passeo-18 Lux
Clinical Study IdentifierNCT04250909
SponsorBiotronik AG
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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