Sirolimus Coated Balloon for Below-the-Knee Arterial Disease
This study is testing a new treatment for peripheral arterial disease (PAD) in your legs, specifically below the knee. It compares a special balloon coated with sirolimus (MagicTouch PTA Sirolimus drug coated balloon) to a standard balloon angioplasty. Both treatments involve using a standard balloon first to open the artery. The goal is to see if the sirolimus-coated balloon is more effective and safe at keeping your arteries open for longer. You might be able to join if you are at least 21 years old and have severe PAD in your legs, classified as Rutherford class 4, 5, or 6. The study will look at how well the arteries stay open after 12 months and also check for safety after 6 months and 30 days. The current recruitment status is unclear.
- Study design
- This is a randomized, placebo-controlled study involving about 368 participants across approximately 80 sites. You would be randomly assigned to receive either the sirolimus-coated balloon or a placebo balloon, in addition to standard angioplasty.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will follow participants for 12 months to check how well the arteries stay open, and for 6 months and 30 days to monitor safety.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease
At a glance
Conditions
Where it's being run
29 sites across 12 statesStudy leadership
- Sahil Parikh, MD · STUDY_CHAIR · New York-Presbyterian/Columbia University Irving Pavilion
Who to contact
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What this trial measures
- Primary patency at 12 months defined as freedom from Target Vessel Occlusion, Binary Restenosis, Clinically-Driven Target Lesion Revascularization and Major Amputation.12 months
Binary restenosis will be defined as the proportion of subjects with duplex ultrasonography-derived peak systolic velocity ratio of \> 2.0 with correlating factors. If the PSV at the reference area in the vessel is abnormal, the core laboratory will employ the following other criteria to diagnose a stenosis of \> 50%: * Monophasic/ low resistive waveforms (parvus tardus) at the stenotic area or distal to an acoustic shadow * Post-stenotic turbulence distal to the stenosis, along with a decrease in peak systolic velocities Gray scale/ B-mode imaging demonstrates significant plaque with stenosis along with a focal increase in the absolute PSV value. * Occlusion = Absence of color filling and spectral Doppler signal.
- Composite safety endpoint6-months for n.1 and n.2; 30 days for n.3
Proportion of subjects who experienced any of the following: 1. 6-month above ankle major amputation of the index limb, 2. 6-month major re-intervention (i.e., angioplasty of target lesion, new bypass graft, jump/interposition graft, or thrombectomy or thrombolysis) 3. Perioperative (30 day) mortality.