Sonodynamic Therapy in the Treatment of Perivascular Adipose Tissue on Patients With PAD and Claudication
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 主要终点
- Change in PVAT Density, as assessed by CTA
研究概览
简要总结
The purpose of this trial is to evaluate the safety and efficacy of sonodynamic therapy (SDT) in reducing the inflammation of perivascular adipose tissue and increasing peak walking time (PWT) among peripheral artery disease (PAD) patients with symptom of intermittent claudication.
详细描述
Atherosclerotic lower extremity PAD affects the living quality of more than 20 million people in the world. PAD is associated with a major decline in functional status and claudication is the most evident symptom. Current claudication therapies reveal significant limitations. Pharmacotherapy and exercise are recommended in 2016 AHA/ACC Guideline on the management of lower extremity PAD patients with claudication. However, they may not achieve an ideal clinical therapeutic effect. Furthermore, endovascular procedure may not be feasible, durable or cost-effective, especially in femoropopliteal arteries.
The aim of this trial is to verify the hypothesis that SDT can reduce the inflammation of PVAT and improve PWT among PAD patients with symptom of intermittent claudication.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 40-80 years
- •Patients with atherosclerotic peripheral artery disease with symptoms of moderate to severe intermittent claudication (defined as ability to walk at least 2, but not more than 11 minutes on a graded treadmill test using the Gardner protocol)
- •Femoral popliteal artery with 50% stenosis by ultrasound
- •Stable use of low to moderate dose statin and the permitted statin drugs/ doses: atorvastatin 20 mg, simvastatin 40 mg, rosuvastatin 10 mg, pravastatin, 40 mg, fluvastatin 80 mg or lovastatin 40 mg for at least 6 weeks prior to screening
- •Written informed consent
排除标准
- •Severe aorto-iliac arteries stenosis or occlusion documented by noninvasive and invasive anatomic assessments
- •Critical limb ischemia or other comorbid conditions that limit walking ability
- •Non-atherosclerotic peripheral artery stenosis
- •Active systemic inflammatory disease or have an infectious disease within 1 month prior to enrollment
- •Systemic disorders such as hepatic, renal, hematologic, and malignant disease
- •Allergic to contrast media with iodine
- •Contraindication to CTA
- •Allergic to DVDMS
- •Diagnosis of porphyria
- •Pregnant women and nursing mothers
- •Patient who is attending other clinical trial
结局指标
主要结局
Change in PVAT Density, as assessed by CTA
时间窗: Measured at Baseline, 1, 3 months
The changes in CT attenuation (HU) of perivascular adipose tissue(PVAT) as assessed by CTA.
次要结局
- Plasma adipokines level(Measured at Baseline, 1, 3 months)
- Plasma inflammation cytokine level(Measured at Baseline, 1, 3 months)
- PWT change, mins(Measured at Baseline, 1, 3 months)
- Incidence of adverse events(Measured at Baseline, 1, 3 months)
- Change in peak flow velocity, as assessed by doppler ultrasound(Measured at Baseline, 1, 3 months)