Trials / Active Not Recruiting
Active Not RecruitingNCT04772300
Trial to Assess the Safety and Efficacy of Sirolimus-Coated Balloon vs. Uncoated Standard Angioplasty for the Treatment of Below-the-knee Peripheral Arterial Disease
Prospective Multi-Center Randomized Controlled Trial to Evaluate the Safety and Efficacy of SiroLIMus Drug Coated Balloon Versus Non-coated Standard Angioplasty for the Treatment of Infrapopliteal Occlusions in Patients With PEripheral Arterial DiSease
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 230 (estimated)
- Sponsor
- Jena University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is a prospective, interventional, multicenter 1:1 randomized trial. The trial evaluates the safety and efficacy of the Magic Touch PTA sirolimus drug-coated balloon in comparison to the treatment with POBA (control device) in patients with advanced infrapopliteal artery disease.
Detailed description
The purpose of this study is to assess whether efficacy of the MagicTouch® Sirolimus Coated PTA Balloon Catheter (SRL-DCB) is superior and whether safety is non-inferior to Plain Old Balloon Angioplasty (POBA) regarding treatment of high-grade stenoses ≥ 75 % in the infrapopliteal arteries (located below the P3 segment of the popliteal artery to the tibiotalar joint) in patients presenting with chronic limb-threatening ische-mia (CLTI) (Rutherford 4-6).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Percutaneous Transluminal Angioplasty (PTA) MagicTouch Sirolimus Coated PTA Balloon Catheter | PTA with an sirolimus drug-coated balloon catheter (SRL-DCB) in the infrapopliteal artery |
| DEVICE | Percutaneous Transluminal Angioplasty (PTA) with non-coated balloon catheter (POBA) | PTA with an non-coated balloon catheter (POBA) in the infrapopliteal artery |
Timeline
- Start date
- 2022-02-10
- Primary completion
- 2026-04-17
- Completion
- 2028-11-17
- First posted
- 2021-02-26
- Last updated
- 2025-12-26
Locations
19 sites across 2 countries: Austria, Germany
Source: ClinicalTrials.gov record NCT04772300. Inclusion in this directory is not an endorsement.