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

Biotronik

Status: Completed

Conditions: Overall Mortality

Treatments: Device: Passeo-18 Lux; Device: Passeo-18

Study type: Observational

Funder types: Industry

Identifiers

NCT04250909

C1901

Details and patient eligibility

About

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.

Enrollment: 132 patients

Sex: All

Ages: Under 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

132 participants in 2 patient groups

Passeo 18 PTA

Description:

Previous treatment with uncoated Passeo 18 PTA balloon catheter

Treatment:

Device: Passeo-18

Passeo-18 Lux DCB

Description:

Previous teatment with Passeo-18 Lux DCB

Treatment:

Device: Passeo-18 Lux