NCT05434676Unknown不适用
Clinical Trial of The ShOckwave Medical Peripheral Lithoplasty® System Used to Treat Moderate and Severely CalcIfied FemOropopliteal Arteries in ChiNese Patients (SOLUTION Trial)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 5
- 主要终点
- Major Adverse Event (MAE) at 30 days
研究概览
简要总结
This is a prospective, multicenter, single arm study, to support the safety and effectiveness assessment of the Shockwave Medical Peripheral IVL System applied to Chinese patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject or subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form.
- •Age of subject is > 18 and ≤80, male or female.
- •Rutherford Category 2 to 5 of the target limb (If both limbs are eligible for the study, one limb will be selected as the target limb at the discretion of the investigator)
- •Estimated life expectancy >1 year.
- •Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guideline.
- •Subject is intended to undergo treatment with IVL followed by DCB. Angiographic
- •Target lesion that is located in a native, de novo superficial femoral artery (SFA) or popliteal artery
- •Target lesion reference vessel diameter is between 4.0mm and 7.0mm by visual estimate.
- •Target lesion is ≥70% stenosis by investigator via visual estimate.
- •Target lesion length is ≤180mm for lesions 70-99% stenosed. Target lesion can be all or part of the 180mm treated zone.
- •Chronic total occlusion (CTO), lesion length is ≤100mm of the total ≤180mm target lesion.
- •Subject has at least one patent tibial vessel on the target leg with runoff to the foot, defined as no stenosis >50%.
- •Calcification is at least moderate defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending > 50% the length of the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is <50mm in length.
排除标准
- •Subject has active infection requiring antibiotic therapy.
- •Planned target limb major amputation (above the ankle).
- •History of prior endovascular or surgical procedure on the index limb within the past 30 days or planned within 30 days of the index procedure.
- •Subject has a known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter.
- •Subject in whom antiplatelet or anticoagulant therapy is contraindicated.
- •Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
- •Subject has known allergy to urethane, nylon, or silicone.
- •Myocardial infarction within 60 days prior to enrollment.
- •History of stroke within 60 days prior to enrollment.
- •History of thrombolytic therapy within two weeks of enrollment.
- •Serum creatinine greater than 2 times the upper reference limit
- •Subject is pregnant or nursing.
- •Women of childbearing potential (18 years to less than 2 years post-menopausal and not surgically sterile) with positive blood or urine pregnancy test at screening
- •Subject is participating in another research study that has not reached the primary endpoint.
- •Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post- treatment.
- •The use of specialty balloons (Scoring or cutting balloon), re-entry or atherectomy devices.
- •Angiographic
- •In-stent restenosis within 10mm of the target zone.
- •Lesions within 10mm of the ostium of the SFA or within 10mm of the ostium of the anterior tibial artery.
- •Evidence of aneurysm or thrombus in target vessel.
- •No calcium or mild calcium in the target lesion.
- •Target lesion within native or synthetic vessel grafts.
- •Subject has significant non-target lesion (>50% stenosis or occlusion) within target limb (e.g. iliac or common femoral) not successfully treated prior to treatment of the target lesion.
- •Subject requires treatment of a peripheral lesion on the ipsilateral limb distal to target site at the time of the index procedure.
- •Failure to successfully cross the guidewire across the target lesion; successful crossing defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations.
研究组 & 干预措施
IVL group
Experimental
Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System M5 or S4
干预措施: Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System M5 & S4 (Device)
结局指标
主要结局
Major Adverse Event (MAE) at 30 days
时间窗: 30 days post index procedure
defined as: * Need for emergency surgical revascularization of target limb * Unplanned target limb major amputation (above the ankle) * Symptomatic thrombus or distal emboli that require surgical, mechanical or pharmacologic means to improve flow and extend hospitalization * Perforations that require an intervention, including bail-out stenting
Procedural success
时间窗: Immediately post index procedure
defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) post IVL treatment (prior to DCB)by angiographic core lab
次要结局
未报告次要终点
研究者
研究点 (5)
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