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

Overall Mortality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04250909
• Other study ID #: C1901
• Status: Completed
• Start date: February 25, 2020
• Est. completion date: July 5, 2021

Study information

• Verified date: August 2021
• Source: Biotronik AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: July 5, 2021
• Est. primary completion date: June 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 100 Years

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

Related Conditions & MeSH terms

• Overall Mortality

Intervention

Device:
• Passeo-18
POBA
• Passeo-18 Lux
DCB

Locations

Country	Name	City	State
Austria	LKH Univ.-Klinikum Graz, Ambulanz für Angiologie	Graz
Austria	Allgemeines Krankenhaus - Universitätsklinik für Radiodiagnostik, Klinische Abteilung für Kardiovaskuläre und Interventionelle Radiologie	Vienna
Belgium	Vascular Research Center Bornheiden, Imelda Hospital	Bonheiden
Belgium	A.Z. Sint-Blasius	Dendermonde
Germany	Clinic of Cardiology and Angiology II Bad Krozingen	Bad Krozingen
Germany	Gefäßzentrum am KEH	Berlin
Germany	University Leipzig Medical Centre Medizinische Klinik und Poliklinik V (Angiologie)	Leipzig
Germany	Institut für Diagnostische und Interventionelle Radiologie, RoMed Klinikum	Rosenheim

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik AG

Countries where clinical trial is conducted

Austria,  Belgium,  Germany, 

Outcome

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