Sonodynamic Therapy in the Treatment of Perivascular Adipose Tissue on Patients With PAD and Claudication

Phase 1

Withdrawn

• Conditions: Peripheral Arterial Disease
• Interventions: Combination Product: Sonodynamic therapy(SDT)

• Registration Number: NCT03967730
• Lead Sponsor: First Affiliated Hospital of Harbin Medical University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-05-27
• Study First Submitted QC: 2019-05-27
• Study First Posted: 2019-05-30
• Study Start: 2019-06-20
• Primary Completion: 2020-05-30
• Study Completion: 2020-05-30
• Last Update Submitted: 2021-04-13
• Last Update Posted: 2021-04-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sonodynamic therapy(SDT)	Sonodynamic therapy(SDT)	Sonodynamic therapy(SDT) treatment is the combination of sonosensitizer administration and target atherosclerotic lesions ultrasound exposure.

Primary Outcome Measures

Name	Time	Method
Change in PVAT Density, as assessed by CTA	Measured at Baseline, 1, 3 months	The changes in CT attenuation (HU) of perivascular adipose tissue(PVAT) as assessed by CTA.

Secondary Outcome Measures

Name	Time	Method
Plasma adipokines level	Measured at Baseline, 1, 3 months	Including adiponectin, vaspin, apelin, leptin, visfatin, resistin and FABP
Plasma inflammation cytokine level	Measured at Baseline, 1, 3 months	Including Interleukin-6(IL-6), IL-10, IL-1β, TGF-α, CRP, EGF, glutathione(GSH) and TGSH.
PWT change, mins	Measured at Baseline, 1, 3 months	Changes from baseline peak walking time (PWT) at 1 month is assessed by graded treadmill test (Gardner protocol). The patient continues the test until walking can no longer be tolerated because of claudication symptoms.
Incidence of adverse events	Measured at Baseline, 1, 3 months	Allergic to sunshine,hepatic or renal dysfunction,thyroid dysfunction
Change in peak flow velocity, as assessed by doppler ultrasound	Measured at Baseline, 1, 3 months	The changes of the systolic and diastolic peak flow velocity of the affected segments by doppler ultrasound.