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.
Subject age ≥ 21 years
Subject has been informed of the nature of the trial, the duration of the trial, agrees to attend follow-up visits, agrees to complete the required testing, agrees to participate, and has signed an informed consent form.
Rutherford category 2-4 according to the investigator's subjective evaluation
Subject has de-novo or re-stenosed lesion with ≥ 70% stenosis documented angiographically, and no prior stent in the target lesion.
Failure of the guidewire to successfully cross the target lesion or subintimal target lesion.
Flow-limiting dissection after pre-dilatation and/or residual stenosis > 30% prior to randomization.
Angiographic evidence of severe calcification of the target vessel (contiguous calcification on both sides of the vessel).
Presence of fresh/organized thrombus in the target lesion.
Parallel
Sirolimus (RAPAMUNE) drug-coated balloon angioplasty catheter
Combination productSirolimus 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 drug-coated balloon angioplasty
Combination productPaclitaxel, 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.
Vessel Patency Rate & Freedom from Post-Procedure Complications after One Year (12 months)
Measured by the absence of clinically driven target lesion revascularization (CD-TLR) due to symptoms and a drop of ABI of ≥ 20% or \> 0.15 when compared to post-procedure or restenosis with PSVR \> 2.4 evaluated by duplex ultrasound. Also, a composite of freedom from device and procedure-related death through 12-months post procedure, as well as freedom from target limb major amputation and clinically driven target vessel revascularization
Long-term Safety and Efficacy of the Treated Vessel
1. Vesel patency at 6, 12, 24, and 48-month \& free of clinically-driven TLR at 1, 6, 12, 24, 36, 48, and 60-month 2. Sustained clinical improvement: an improvement shift in the Rutherford classification of at least one category in amputation and TVR-free surviving subjects at 12 months 3. Change in walking capacity assessment from pre-procedure to the respective follow-up visits 4. Duplex-defined binary restenosis (PSVR \> 2.4) of the target lesion post-procedure and at 6, 12, \& 24-months, or at any time of re-intervention 5. Hemodynamic improvement is defined as an increase in resting ankle brachial index (ABI) from pre-procedure to discharge, 6, 12, 24, and 48-months 6. Change in quality-of-life (QoL) assessment by VascuQol questionnaire and EQ5D-5L index questionnaire from pre-procedure through applicable follow-up visits 7. All-cause mortality at 1, 6, 12, 24, 36, 48, and 60-month 8. Target limb major amputation at 1, 6, 12, 24, 36, 48, and 60-month
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