Trials / Active Not Recruiting
Active Not RecruitingNCT04971772
SIGNATURE Study : DCB (Legflow) vs POBA in Fempop Arteries
SIGNATURE Study: Post-market, Randomized Controlled, Multicenter, Single Blinded Prospective Trial Investigating the Paclitaxel-Coated Balloon (Legflow DCB) Treatment Versus Uncoated Balloon Angioplasty Treatment for Femoro-popliteal Lesions.
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (actual)
- Sponsor
- Cardionovum GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to demonstrate the superiority in safety and efficacy of the Legflow DCB vs standard uncoated POBA in a randomized controlled (RCT) for treatment of patients with symptomatic peripheral artery disease (PAD) due to stenosis, restenosis or occlusion of the femoral and/or popliteal arteries.
Conditions
Timeline
- Start date
- 2022-06-08
- Primary completion
- 2026-12-01
- Completion
- 2028-01-01
- First posted
- 2021-07-21
- Last updated
- 2026-03-19
Locations
11 sites across 3 countries: Brazil, Germany, Switzerland
Source: ClinicalTrials.gov record NCT04971772. Inclusion in this directory is not an endorsement.