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
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Peripheral Artery Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 1:1-randomization, parallel design, stratified by center.Masking: Double (Participant, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The primary 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 noninferior to Plain Old Balloon Angioplasty (POBA) regarding treatment of occlusions in the infrapopliteal arteries (located below the ...
The primary 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 noninferior to Plain Old Balloon Angioplasty (POBA) regarding treatment of occlusions in the infrapopliteal arteries (located below the P3 segment of the popliteal artery to the tibiotalar joint) in patients pre-senting with chronic limb-threatening ischemia (CLTI) (Rutherford 4-6).
Tracking Information
- NCT #
- NCT04772300
- Collaborators
- Concept Medical Inc.
- VascuScience GmbH
- CoreLab Black Forest
- Centrer for Clinical Studies Jena
- Investigators
- Study Director: Ulf Teichgraeber, Prof. Dr. University Hospital Jena, Institute of Radiology
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