Trials / Completed
CompletedNCT03052309
BIOLUX P-III BENELUX All-Comers Registry
BIOTRONIK - A Prospective, International, Multi-centre, Post-market All-comers Registry to Assess the Clinical Performance of the Passeo-18 Lux Paclitaxel Releasing Balloon Catheter in Popliteal Arteries - III BENELUX
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 106 (actual)
- Sponsor
- Biotronik AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the BIOLUX P-III BENELUX Registry is to further investigate the safety and clinical performance of the Passeo-18 Lux Drug Coated Ballon when used in daily clinical practice for the treatment of isolated atherosclerotic lesion (vessel narrowing) in popliteal arteries
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Passeo-18 Lux DCB | The decision to treat the patient with Passeo-18 DCB is at the investigator discretion. The endovascular procedure is performed as per standard of care and device Instructions For Use (IFU) |
Timeline
- Start date
- 2017-02-24
- Primary completion
- 2020-06-09
- Completion
- 2021-04-27
- First posted
- 2017-02-14
- Last updated
- 2022-08-15
Locations
9 sites across 3 countries: Belgium, Luxembourg, Netherlands
Source: ClinicalTrials.gov record NCT03052309. Inclusion in this directory is not an endorsement.