Sonodynamic Therapy Manipulate Atherosclerosis Regression Trial Among Patients With Femoropopliteal PAD and Claudication
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 主要终点
- MDS TBR change, (%)
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 atherosclerotic plaques inflammation 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 more than 20 million people in the world. PAD is associated with a major decline in functional status and claudication is the most frequent symptom. Current claudication therapies are associated with significant limitations. Pharmacotherapy cilostazol and supervised exercise are recommended in 2016 AHA/ACC Guideline on the management of lower extremity PAD patients with claudication, but cilostazol may not achieve an ideal response rate, and supervised exercise efficacy may be limited by co-morbidities and medicare reimburse. Furthermore endovascular procedure may not be feasible, durable or cost-effective, especially in femoropopliteal arteries.
The aim of this trial is to test the hypothesis that SDT improves PWT by inhibiting atherosclerotic plaques inflammation in femoropopliteal arteries PAD patients compared to optimal medical care (OMC) within 6 month. An estimated 80 eligible patients will be randomly divided into tow groups: OMC and SDT combined with OMC. Recruitment will be performed over 6 months and patients will be followed for 6 months; the anticipated total study duration will be 2 years.
Finally, this trial investigate the safety and efficacy of SDT in PAD patients with intermittent claudication and explore new end-points to evaluate therapeutic effects using PET-CT imaging as well as traditional endpoints.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
- •Aged ≥40 years
- •Resting ABI < 0.9 or ABI decreases > 0.15 after treadmill test regardless of the ABI at rest
- •Presence of significant stenosis but not occlusion of femoropopliteal arteries including the common femoral artery, superficial femoral artery and popliteal artery as determined by: Duplex ultrasound imaging OR lower extremity computed Tomography Angiography (CTA) OR lower extremity magnetic resonance angiography (MRA) OR lower extremity catheter-based contrast arteriography. Each of these noninvasive and invasive anatomic assessments will identify patients with at least a 50% stenosis in the affected segment
- •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
- •Critical limb ischemia or other comorbid conditions that limit walking ability (claudication must be the consistent primary exercise limitation)
- •Inability to complete treadmill testing per protocol requirements
- •Two treadmill tests are completed at baseline to confirm reproducibility of results; those who deviates >25% are excluded
- •Severe aorto-iliac arteries stenosis or occlusion documented by noninvasive and invasive anatomic assessments
- •Allergic to DVDMS
- •Diagnosis of porphyria
- •Pregnant women and nursing mothers
- •Contraindications of PET/CT
- •Concurrent enrollment in another clinical trial
- •Presence of any clinical condition that in the opinion of the principal Investigator or the sponsor makes the patient not suitable to participate in the trial
研究组 & 干预措施
Optimal Medical Care
Optimal medical care (OMC) only is administrated in this arm. OMC is established according to the standards established by the 2016 ACC-AHA Guidelines for the Management of Patients with Peripheral Artery Disease in order to promote best practices for risk factor management.
干预措施: Optimal Medical Care (Drug)
Optimal Medical Care and SDT
OMC and sonodynamic therapy (SDT) are administrated in this arm.
干预措施: Optimal Medical Care (Drug)
Optimal Medical Care and SDT
OMC and sonodynamic therapy (SDT) are administrated in this arm.
干预措施: Sonodynamic therapy (Combination Product)
结局指标
主要结局
MDS TBR change, (%)
时间窗: Measured at baseline, 1 and 3 months.
Change from baseline most disease segments (MDS) at 3 months is assessed by 18FDG-PET imaging. Uptake of FDG by the common and superficial femoral artery is expressed as the target, vessel wall to background, lumen ratio (TBR). The mean max MDS TBR is defined as the arterial segment centered on the slice of artery demonstrating the highest FDG uptake at baseline within the index vessel, and calculated as a mean of maximum TBR values derived from three contiguous axial segments.
PWT change, mins
时间窗: Measured at baseline, 1, 3 and 6 months.
Change from baseline peak walking time (PWT) at 6 months is assessed by graded treadmill test (Gardner protocol). The patient continues the test until walking can no longer be tolerated because of claudication symptoms.
次要结局
- COT change, mins(Measured at baseline, 1, 3, and 6 months.)
- Peak flow velocity, (cm/s)(Measured at baseline, 1, 3, and 6 months.)
- Serum inflammation cytokine level(Measured at baseline, 1, 3, and 6 months.)
- Post-exercise ABI(Measured at baseline, 1, 3, and 6 months.)
- AS TBR change, (%)(Measured at baseline, 1 and 3 months.)
- WV TBR change, (%)(Measured at baseline, 1 and 3 months.)
- Pre-exercise ABI(Measured at baseline, 1, 3, and 6 months.)
- Vessels' diameter, (mm)(Measured at baseline, 1, 3, and 6 months.)
- Diameter stenosis, (%)(Measured at baseline, 1, 3, and 6 months.)
- WIQ score(Measured at baseline, 1, 3, and 6 months.)
- Intimal-medial thickness, (mm)(Measured at baseline, 1, 3, and 6 months.)
- SF-36 score(Measured at baseline, 1, 3, and 6 months)