MAGICTouchTM PTA Sirolimus-Coated BALloon vs Paclitaxel Coated Balloon for Treatment of High-grade Stenotic or Occluded Lesions in Femoro-Popliteal Arteries
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 478
- 主要终点
- Vessel Patency Rate & Freedom from Post-Procedure Complications after One Year (12 months)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Parties will remain masked until the primary endpoint is passed. Masking will be maintained as best as can be for care providers beyond those directly responsible for the index procedure.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Target lesion length is ≥ 40mm and ≤ 200mm by visual estimate of the treating physician.
- •Multiple lesions with max. A 30mm healthy vessel segment between lesions can be considered, at the treating physician's discretion, as one lesion. Total lesion length should not exceed 200mm.
- •Reference vessel diameter (RVD) ≥ 4mm and ≤ 7 mm by visual estimation.
- •Patency of P2 and P3 segments of the popliteal artery and at least one (1) infra-popliteal artery to the ankle (< 50% diameter stenosis) in continuity with the femoropopliteal artery.
- •Patency of the ipsilateral iliac artery (≤ 30% diameter stenosis). Iliac artery stenosis > 30% may be treated during the index procedure to ensure sufficient inflow.
- •Staged Intervention of the contralateral limb is permitted at +/- 30 days.
- •A subject can only be enrolled and randomized once with only one target lesion in the MAGICAL SFA trial. Note that only the lesion in one limb can be treated as a target lesion for the index procedure.
排除标准
- •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.
- •Presence of aneurysm in the target vessel/s.
- •Prior vascular surgery (including atherectomy , bypass surgery) of the target limb.
- •Prior stent in the target lesion.
- •Stroke or heart attack within three months prior to enrollment.
- •Any vascular surgical procedure or intervention performed in the target limb within 30 days prior to or planned within 30 days post index procedure.
- •Any vascular treatment with PTX or sirolimus-coated devices 60 days prior to the index procedure.
- •Target lesion requires treatment with alternative therapies such as primary stenting, laser, lithotripsy, thrombectomy, atherectomy, and/or cryoplasty brachytherapy re- entry devices.
- •Enrolled in another investigational drug, device, or biologic trial where the primary end point is not yet achieved.
- •Life expectancy of less than one year in the investigator's opinion.
- •Known allergies or sensitivity to heparin, aspirin, other anticoagulant/antiplatelet therapies, sirolimus, paclitaxel, or contrast media that cannot be adequately pre- treated prior to index procedure.
- •Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.
- •Receiving dialysis or immunosuppressant therapy . (A systemic corticosteroid therapy with expected maximum dosage of 5mg prednisolone or equivalent, per day, during the initial 9 months after procedure, is allowed.)
- •Subjects with severe (Stage 4) renal disease, defined as eGFR < 30%.
- •Pregnant or lactating females .
- •History of major amputation in the target lesion limb.
研究组 & 干预措施
MagicTouch sirolimus drug coated angioplasty balloon
Subjects randomized to this arm will receive the experimental device during the angioplasty procedure to treat the affected vessel lesion that was occluded or stenosed.
干预措施: Sirolimus (RAPAMUNE) drug-coated balloon angioplasty catheter (Combination Product)
Paclitaxel drug coated angioplasty balloon
Subjects randomized to this arm will receive the control device during the angioplasty procedure to treat the affected vessel lesion that was occluded or stenosed.
干预措施: Paclitaxel drug-coated balloon angioplasty (Combination Product)
结局指标
主要结局
Vessel Patency Rate & Freedom from Post-Procedure Complications after One Year (12 months)
时间窗: One year from index procedure
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
次要结局
- Long-term Safety and Efficacy of the Treated Vessel(Up to five years after index procedure)