Trials / Suspended
SuspendedNCT04815473
AndraValvulotome Post-Market Study
- Status
- Suspended
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 59 (actual)
- Sponsor
- Andramed GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The AndraValvulotome Post-Market Study is a prospective, open-label, multi-center study to evaluate the efficacy and safety of the AndraValvulotome. A maximum of 70 patients will be enrolled with peripheral artery disease (PAD) in up to 10 sites. Study participants will be primarily observed during the bypass procedure. In addition, the patients will be re-evaluated at the follow-up visit which will be scheduled 30 +/- 7 days after beginning of the study participation. The objective of this study is to analyze the efficacy and safety of the valvulotomy of the venous valves with the CE marked AndraValvulotome during the bypass procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Valvulotomy | Valvulotomy of the venous valves |
Timeline
- Start date
- 2021-04-28
- Primary completion
- 2022-05-30
- Completion
- 2023-12-01
- First posted
- 2021-03-25
- Last updated
- 2023-10-18
Locations
4 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT04815473. Inclusion in this directory is not an endorsement.