Trials / Recruiting
RecruitingNCT05055297
SELUTION4BTK Trial
SELUTION SLR™ 014 BTK: A Prospective Randomized Multicenter Single Blinded Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 Drug Eluting Balloon in the Treatment of Below-the-Knee (BTK) Atherosclerotic Disease in Patients With Chronic Limb Threatening Ischemia (CLTI)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 376 (estimated)
- Sponsor
- M.A. Med Alliance S.A. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION SLR™ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the BTK arteries in CLTI patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SELUTION SLR™ DEB 014 | a non-surgical procedure that uses a catheter to inflate a drug-eluting balloon to open up peripheral below-the-knee arteries that have been narrowed by chronic limb-threatening ischemia |
| DEVICE | Plain (Uncoated) Balloon Angioplasty (PTA) | a non-surgical procedure that uses a catheter to inflate a commercially available, non-drug-eluting balloon to open up peripheral below-the-knee arteries that have been narrowed by chronic limb-threatening ischemia |
Timeline
- Start date
- 2022-05-19
- Primary completion
- 2027-06-01
- Completion
- 2032-07-30
- First posted
- 2021-09-24
- Last updated
- 2026-02-04
Locations
48 sites across 10 countries: United States, Austria, France, Germany, Hong Kong, Italy, Netherlands, New Zealand, Singapore, Switzerland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05055297. Inclusion in this directory is not an endorsement.