Sonodynamic Therapy Manipulates Atherosclerosis Regression Trial on Patients With PAD and Claudication

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria: - 1. 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) - 2. Aged =40 years - 3. Resting ABI < 0.9 or ABI decreases > 0.15 after treadmill test regardless of the ABI at rest - 4. Presence of atherosclerotic plaque in 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 - 5. 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 - 6. Written informed consent Exclusion Criteria: - 1. Critical limb ischemia or other comorbid conditions that limit walking ability (claudication must be the consistent primary exercise limitation) - 2. Inability to complete treadmill testing per protocol requirements - 3. Two treadmill tests are completed at baseline to confirm reproducibility of results; those who deviates >25% are excluded - 4. Severe aorto-iliac arteries stenosis or occlusion documented by noninvasive and invasive anatomic assessments - 5. Active systemic inflammatory disease or have an infectious disease within 1 month prior to enrollment - 6. Allergic to DVDMS - 7. Diagnosis of porphyria - 8. Pregnant women and nursing mothers - 9. Contraindications of PET/CT - 10. Concurrent enrollment in another clinical trial - 11. Presence of any clinical condition that in the opinion of the principal investigator makes the patient not suitable to participate in the trial

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in MDS TBR

Secondary Outcome Measures

Name	Time	Method
AS TBR change, (%);WV TBR change, (%);PWT change, s;COT change, s;Pre-exercise ABI;Diameter stenosis, (%);WIQ score;SF-36 score

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