Trial to Investigate the Shockwave Intravascular Lithotripsy (IVL) on Vascular Compliance in Heavily Calcified Femoropopliteal Disease (PACSS 2-4)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- FDC
研究概览
简要总结
Typical symptoms of PAD include exercise-induced pain in the legs (known as intermittent claudication), which can significantly limit pain-free walking. In more advanced stages, pain may also occur at rest. Additionally, the development of chronic, hard-to-heal wounds-especially on the feet and toes-is possible. These wound healing impairments are caused by the insufficient supply of oxygen and nutrients to the affected tissues.
The underlying cause of PAD is usually atherosclerosis, a pathological change in the vessel walls due to the accumulation of fats, calcium, and connective tissue. These deposits lead to stiffening and narrowing of the arteries, severely restricting blood flow. Major risk factors for the development of PAD include widespread chronic conditions such as diabetes mellitus, hyperlipidemia (elevated blood lipid levels, e.g., cholesterol), arterial hypertension (high blood pressure), obesity, and tobacco use.
Various therapeutic options are available for the treatment of PAD. In addition to conservative therapy (such as supervised exercise training, pharmacological blood thinning, and risk factor management), interventional, minimally invasive treatment using catheter-based techniques is frequently employed. In such procedures, a thin catheter is guided through the vascular system to the affected area of the leg artery. Depending on the type and extent of the arterial narrowing or calcification, one of the following techniques may be applied:
Balloon angioplasty: Dilation of the vessel using an inflatable balloon. Lithoplasty: Application of shockwaves to break down calcifications in the arterial wall.
详细描述
Massive Calcifications in the peripheral vessels lead to altered vascular stiffness. This arterial stiffness is an excellent marker for morbidity and mortality and correlates with the progression of cardiovascular disease. Main pathophysiologic principles are altered pulse wave reflections through arterial and aortic stiffness on cardiac functions. Impaired vascular compliance is associated with increased cardiovascular morbidity and leads to a progression of atherosclerotic lesions, impaired ventriculoarterial coupling and ultimately impaired coronary perfusion.
Vascular calcifications are furthermore held responsible for suboptimal vessel expansion and increased risk of complications including dissection and perforation and reduced long-term patency when treated though the endovascular route. Calcium treatment through IVL gives physicians opportunities to tackle this unmet need. IVL treatment is a safe and effective treatment in these heavily calcified lesions proving excellent procedural success compared to PTA driven by a significantly lower rate of major dissections and need for bail-out stent placement. This was evident also in coronary vessels suggesting that calcium fracture is the IVL-related mechanism to enhance vessel compliance and to assists optimal stent expansion.
The influence of this novel strategies with improved hemodynamic capabilities with respect to vasomotion of the vessel wall, vascular function and vascular compliance can be measured by ultrasound, as shown recently. To which extent intravascular lithotripsy has an impact on vessel compliance has not been elucidated so far and could aid to understand the prognostic beneficial effects of intravascular lithotripsy.
The aim of this investigator-initiated trial is thus to investigate the IVL -related beneficial effect of lesion preparation by altering vascular compliance parameters and vasomotion of the vessel wall.
The primary objective is to determine changes in Vessel compliance, function and stiffness and after IVL treatment compared to POBA in symptomatic PAD.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Peripheral artery disease
- •Severe Calcification PACCS 2,3 and 4
- •Target lesions in distal EIA, CFA, prox. SFA or PA
- •Clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by Rutherford 2, 3, 4 and 5
- •Planed peripheral intervention TASC A-D
- •Subject must be between 18 and 85 years old
- •Willing to comply with the specified follow-up evaluation
- •Written informed consent prior to any study procedures
排除标准
- •Target lesions with no optimal visualization in ultrasound
- •Instent-Restenosis
- •Thrombolysis within 72 hours prior to the index procedure
- •Aneurysm formations in the femoral artery or popliteal artery
- •Concomitant hepatic insufficiency, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy
- •Unstable angina pectoris at the time of the enrolment
- •Recent myocardial infarction or stroke < 30 days prior to the index procedure
- •Life expectancy less than 12 months
- •Septicemia at the time of enrolment
- •Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound of the target limb
- •Known or suspected allergies or contraindications to aspirin, clopidogrel or heparin
结局指标
主要结局
FDC
时间窗: 1 day and 30 days follow-up
To determine changes in vessel compliance before and after IVL treatment and after 1 month compared to POBA in symptomatic PAD as determined by fractional diameter change (FDC).
次要结局
- FMD/NMD analysis of the target lesion(1 day and 30 days follow-up)
- PWV(1 day and 30 days follow-up)
- ABI(1 day and 30 days follow-up)
- Primary patency (PP)(1 day and 30 days follow-up)
- Procedural complications(1 day and 30 days follow-up)
- Dissection rate and Bail-out stenting(1 day and 30 days follow-up)
- Freedom from Target Lesion Revascularization (FTLR)(1 day and 30 days follow-up)
- AIX(1 day and 30 days follow-up)