Phase 2/3Not yet recruiting
A Study Comparing the MAGICTouch™ Sirolimus-coated Balloon With a Paclitaxel-coated Balloon for Treating Severe Narrowing or Blockage in the Femoropopliteal Arteries. (MAGICAL SFA)
MAGICTouchTM PTA Sirolimus-Coated BALloon vs Paclitaxel Coated Balloon for Treatment of High-grade Stenotic or Occluded Lesions in Femoro-Popliteal Arteries
- Sponsor
- Concept Medical Inc. (Industry)
- Enrolment
- 478 planned
- Conditions
- Popliteal Artery Disease; Superficial Femoral Artery Disease
- Interventions
- Sirolimus (RAPAMUNE) drug-coated balloon angioplasty catheter; Paclitaxel drug-coated balloon angioplasty
- Ages
- adults, older adults
- Registry
- NCT07359807
Full record on ClinicalTrials.gov
From the registry
Percutaneous Transluminal Angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries. The long-term success of bare balloon PTA in the femoropopliteal segment is hampered by the occurrence of restenosis, which can be reduced by local antiproliferative drug delivery via the PTA balloon catheter. The rationale of this trial is based on the hypothesis that the usage of the MagicTouch drug-coated balloon (DCB) is at least equal (non-inferior) with regard to efficacy and safety in comparison with a clinically well-established paclitaxel drug-coated balloon (PTX DCB). The objective of this prospective, randomized, multi-center trial is to compare the Magic Touch® DCB with PTX DCBs for treatment of high-grade stenotic or occluded lesions in supeficial femoral artery (SFA) and/or P1 segment of the popliteal artery in PAD patients.
Primary outcomes
- Vessel Patency Rate & Freedom from Post-Procedure Complications after One Year (12 months)
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered