Trials / Completed
CompletedNCT04250909
Retrospective Follow-up of BIOLUX P-I/-II
Retrospective 5-year Safety Analysis of the BIOLUX P-I and P-II Studies in Subjects Requiring Revascularization of Infrainguinal Arteries
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 132 (actual)
- Sponsor
- Biotronik AG · Industry
- Sex
- All
- Age
- 100 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Passeo-18 | POBA |
| DEVICE | Passeo-18 Lux | DCB |
Timeline
- Start date
- 2020-02-25
- Primary completion
- 2021-06-05
- Completion
- 2021-07-05
- First posted
- 2020-01-31
- Last updated
- 2021-08-05
Locations
8 sites across 3 countries: Austria, Belgium, Germany
Source: ClinicalTrials.gov record NCT04250909. Inclusion in this directory is not an endorsement.