Cardiovascular Diseases Clinical Trial
Official title:
Sonodynamic Therapy Manipulates Atherosclerosis Regression Trial on Patients With PAD and Claudication
The purpose of this trial is to evaluate the safety and efficacy of sonodynamic therapy (SDT) on reducing atherosclerotic plaques inflammation among patients with symptomatic femoropopliteal peripheral artery disease.
Atherosclerotic lower extremity PAD affects more than 202 million people in the worldwide.
PAD is associated with a major decline in walking 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.
SDT is a novel anti-inflammatory regimen to atherosclerosis with non-invasive, plaque-based,
macrophage-targeted characteristics. We hypothesize that reducing local arterial inflammation
of affected limb will ameliorate claudication symptom in patients with PAD. The main
objectives of this trial are to evaluate the efficacy and safety of SDT in patients with
symptomatic femoropopliteal PAD.
Thirty-two eligible participants will be randomly assigned to SDT or sham-control groups.
Results of PET/CT are the prespecified primary endpoint.
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