NCT05058456已完成不适用
Prospective, Multi-center, Single-arm Feasibility Study of the Shockwave Medical Mini S Peripheral Intravascular Lithotripsy (IVL) System
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- Primary Safety: Major Adverse Events (MAE)
研究概览
简要总结
Prospective, multi-center, single-arm feasibility study to assess the safety and performance of the Shockwave Medical Mini S Peripheral IVL System for the treatment of heavily calcified, stenotic peripheral arteries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General Inclusion Criteria
- •Age of subject is ≥ 18 years.
- •Subject is able and willing to comply with all assessments in the study.
- •Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and has signed the approved consent form.
- •Estimated life expectancy > 1 year.
- •Rutherford Clinical Category 2, 3, 4 or 5 of the target limb(s).
- •Angiographic Inclusion Criteria
- •One or two target lesion(s) located in a native de novo superficial femoral, popliteal or infrapopliteal artery (above the ankle joint), in one or both limbs.
- •Target lesion reference vessel diameter (RVD) between 2.0 mm and 7.0 mm by investigator visual estimate.
- •Target lesion stenosis ≥70% (for vessels below the knee defined as P3 to the ankle joint) or ≥90% (for vessels above the knee) by investigator visual estimate.
- •Target lesion length is ≤150 mm by investigator visual estimate. Target lesion can be all or part of the 150 mm treated zone.
- •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
- •- General Exclusion Criteria
- •Rutherford Clinical Category 0, 1 and 6 (target limb).
- •History of endovascular or surgical procedure on the target limb within the last 30 days, or planned within 30 days of the index procedure. Note: inflow treatment of non-target lesions is allowed providing successful treatment.
- •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.
- •Subject has acute or chronic renal disease with eGFR <30 ml/min/1.73 m2 (using CKD-EPI formula), unless on renal replacement therapy.
- •Subject is pregnant or nursing.
- •Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) 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.
- •Covid-19 diagnosis within 30 days.
- •Planned use of cutting/scoring balloons, re-entry or atherectomy devices in target lesion(s) during the index procedure.
- •Planned major amputation of target limb.
- •Acute limb ischemia.
- •Occlusion of all the inframalleolar outflow arteries/vessels (i.e., desert foot).
- •Subject already enrolled into this study.
- •Angiographic Exclusion Criteria
- •Failure to treat clinically significant inflow lesions in the ipsilateral iliac, femoral, or popliteal arteries with ≤30% residual stenosis, and no serious angiographic complications (e.g. embolism).
- •Failure to successfully treat significant non-target infra-popliteal lesions, if treated prior to target lesion(s). Successful treatment is defined as obtaining ≤50% residual stenosis with no serious angiographic complications (e.g., embolism).
- •Target lesion includes in-stent restenosis.
- •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.
- •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
Single-arm
Experimental
干预措施: Shockwave Medical Mini S Peripheral IVL Catheter (Device)
结局指标
主要结局
Primary Safety: Major Adverse Events (MAE)
时间窗: 30 days
Major Adverse Events (MAE) at 30 days defined as a composite of: * Cardiovascular Death * Clinically Driven Target Lesion Revascularization (CD-TLR) * Unplanned Target Limb Major Amputation (Above the Ankle)
Primary Performance: Technical Success
时间窗: Peri-Procedural
Technical Success defined as final residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion by angiographic core lab
次要结局
- Serious Angiographic Complications(Peri-Procedural)
- IVL Technical Success (Post- Dilatation)(Peri-Procedural)
- IVL Device Success(Peri-Procedural)
- Technical Success (Final)(Peri-Procedural)
- MAEs at 6-months Post Procedure(6 Months Post-Procedure)
- MAEs at 12-months Post Procedure(12 Months Post-Procedure)
- Primary Patency at 12-Months(12-Months Post Procedure)
研究者
研究点 (4)
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