No-profit, Pilot, Observational, Multicentric, Prospective Study on the Use of Shockwave M5+ IVL Catheter (Intravascular Lithotripsy) in Hostile and Calcified Iliac Access to Facilitate Aortic Endovascular Repair. SHOCK-ACCESS STUDY.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- Minimum Lumen Diameter (MLD) Gain
研究概览
简要总结
The study will evaluate, in a controlled setting, the efficacy and safety of the intravascular lithotripsy using Shockwave™ M5+ Peripheral Intravascular Lithotripsy Catheter to facilitate delivery of aortic large-bore devices in iliac calcified access.
详细描述
This study is designed as no-profit, pilot, observational, multicentric, prospective study.
All eligible subjects for undergoing intervention with Shockwave™ M5+ Peripheral Intravascular Lithotripsy Catheter (IVL) at sites participating in the study will be considered for enrolment and will be asked to give consent prior to participating.
Subjects will be considered enrolled in the study at the time written informed consent is given to the use of their personal data. Once patients are enrolled, their demographics, medical history, disease-relevant conditions, treatment details and outcomes will be collected for up to 12 months from the procedure.
The study will collect information about the medical care patients receive during their planned procedure. No additional testing or procedures will be done.
The procedure with Shockwave™ M5+ Peripheral Intravascular Lithotripsy Catheter (IVL) will be performed as per the current instructions for use.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥18 years old;
- •Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study;
- •Patient presenting with aortic disease indicated for endovascular treatment considered unfeasible based on severely calcified iliac access and outer diameter of the "ideal" aortic endograft at onset of the procedure (considering the main body and/or contralateral limb in case of iliac distal landing zone);
- •Patients presenting a ratio > 0.2 between outer diameter of the aortic stent graft delivery system (OD-SG) and minimum lumen diameter (MLD); decision concerning SG will be taken balancing the lower profile on the market and the better graft fit for patient's anatomy;
- •Patients presenting calcium grade 3 or 4 accordingly to 360° coronary classification (grade 1 = 0-90°, grade 2 = 90°-180°; grade 3 = 180°-270°; grade 4 = 270°-360°);
- •Patients presenting a lesion length > 20 mm, intended as the sum of all calcified iliac lesions between two endpoints, from the aortic bifurcation up to the proximal common femoral artery (CFA);
- •Patients eligible for treatment with Shockwave M5+ IVL device;
- •Patients presenting with aortic disease indicated for endovascular treatment associated or not to aorto-iliac occlusive disease (Rutherford classification score II - VI for chronic limb ischemia);
- •Patients compliant with the conduct of follow-up visits according to the timelines specified in the protocol.
排除标准
- •Bilateral Iliac Occlusion;
- •Urgent setting with presence of iliac thrombus (acute limb ischemia);
- •Any patient considered to be hemodynamically unstable at procedure onset;
- •Patients refusing treatment;
- •Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated;
- •Patients with a history of prior life-threatening contrast medium reaction;
- •Life expectancy of less than twelve months.
结局指标
主要结局
Minimum Lumen Diameter (MLD) Gain
时间窗: Baseline, Day 1
Minimum Lumen Diameter (MLD) Gain defined as the difference between MLD post-procedure and MLD pre-procedure.
次要结局
- Freedom from vessel flow-limiting dissections(Day 1, 1 Month)
- Freedom from iliac secondary procedures(Day 1)
- Technical success of Shockwave™ M5+ IVL(Day 1)
- Composite of Freedom from iliac complications(Day 1, 1 Month)
- Freedom from vessel distal embolization(Day 1, 1 Month)
- Freedom from bailout manoeuvres(Day 1)
- Freedom from access-site adjunctive/secondary procedures;(Day 1)
- All-cause mortality(1 month, 6 months, 12 moths)
- Rutherford shift(1 month, 6 months, 12 months)
- Procedural Success(Day 1)
- Clinical Success(Day 1, 1 month)
- Freedom from vessel trauma(Day 1, 1 Month)
- Freedom from vessel rupture(Day 1, 1 Month)
- Primary patency of the target lesion for each iliac axis treated with IVL(1 month, 6 months, 12 months)
- Freedom from SAE(Day 1, 1 month)
- Freedom from Clinically-driven TLR(1 month, 6 months, 12 months)
- Device Success(Day 1)
- Freedom from procedure related complications(Day 1)
- CASS score (exploratory endpoint)(Baseline)