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

Completed

• Conditions: Overall Mortality
• Interventions: Device: Passeo-18; Device: Passeo-18 Lux

• Registration Number: NCT04250909
• Lead Sponsor: Biotronik AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-30
• Study First Submitted QC: 2020-01-30
• Study First Posted: 2020-01-31
• Study Start: 2020-02-25
• Primary Completion: 2021-06-05
• Study Completion: 2021-07-05
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-04
• Last Update Posted: 2021-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Passeo 18 PTA	Passeo-18	Previous treatment with uncoated Passeo 18 PTA balloon catheter
Passeo-18 Lux DCB	Passeo-18 Lux	Previous teatment with Passeo-18 Lux DCB

Primary Outcome Measures

Name	Time	Method
Overall survival	60 months	Overall survival at five years after index procedure, defined as death from any cause

Secondary Outcome Measures

Name	Time	Method
Major amputations of target extremities	60 months
Overall survival, defined as the time in days after index procedure to date of death from any cause.	60 months
Clinically-driven target lesion revascularization	60 months
Cause of death (descriptive analysis) at five years after treatment within BIOLUX P-I/-II.	60 months

Trial Locations

Locations (8)

Vascular Research Center Bornheiden, Imelda Hospital; 🇧🇪 Bonheiden, Belgium

Clinic of Cardiology and Angiology II Bad Krozingen; 🇩🇪 Bad Krozingen, Germany

Gefäßzentrum am KEH; 🇩🇪 Berlin, Germany

Institut für Diagnostische und Interventionelle Radiologie, RoMed Klinikum; 🇩🇪 Rosenheim, Germany

University Leipzig Medical Centre Medizinische Klinik und Poliklinik V (Angiologie); 🇩🇪 Leipzig, Germany

LKH Univ.-Klinikum Graz, Ambulanz für Angiologie; 🇦🇹 Graz, Austria

A.Z. Sint-Blasius; 🇧🇪 Dendermonde, Belgium

Allgemeines Krankenhaus - Universitätsklinik für Radiodiagnostik, Klinische Abteilung für Kardiovaskuläre und Interventionelle Radiologie; 🇦🇹 Vienna, Austria