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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
478
Sirolimus is used outside the United States to block cell growth, cell proliferation (especially T-cells), and angiogenesis (new blood vessel formation). This experimental device uses proprietary technology to adhere sirolimus to the balloon catheter, deliver it to the affected vessel, and ultimately be absorbed by the surrounding tissue.
Paclitaxel, which is used in cancer chemotherapy for various indications, is a drug that disrupts normal microtubule function and prevents neointimal hyperplasia by inhibiting smooth muscle cell migration, proliferation, and extracellular matrix secretion and is currently used in the United States.
Primary Efficacy Endpoint
The absence of clinically driven target lesion revascularization (CD-TLR) due to symptoms and drop of ABI of ≥ 20% or \> 0.15 when compared to post-procedure or restenosis with PSVR \> 2.4 evaluated by duplex ultrasound.
Time frame: One year from index procedure
Secondary Safety Endpoint
Freedom from device and procedure-related death through 12 months post-procedure, as well as freedom from both target limb major amputation and clinically driven target vessel revascularization.
Time frame: One year after index procedure
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