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

NCT ID: NCT03967730

Last Updated: 2021-04-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-20
• Study Completion Date: 2020-05-30

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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sonodynamic therapy(SDT)

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

Group Type: EXPERIMENTAL

Sonodynamic therapy(SDT)

Intervention Type: COMBINATION_PRODUCT

Sonodynamic Therapy (SDT) Sinoporphyrin Sodium (DVDMS) as sonosensitizer, is dissolved in 0.9% sodium solution for following skin test and intravenous injection. 0.01mg/ml DVDMS solution (0.1ml) is prepared for skin test followed by 0.04 mg/ml DVDMS solution intravenous injection(0.2mg/kg).The target atherosclerotic lesions are marked on the corresponding skin with ultrasound guidance and underwent ultrasound exposure after 4 hours incubation. The therapeutic ultrasonic transducer is fixed to the marked skin site for 15 min of each lesion. Ultrasound parameters included intensity of 2.1W/cm2 for each lesion, resonance frequency: 1.0 MHz and duty factor: 30%.

Interventions

Sonodynamic therapy(SDT)

Sonodynamic Therapy (SDT) Sinoporphyrin Sodium (DVDMS) as sonosensitizer, is dissolved in 0.9% sodium solution for following skin test and intravenous injection. 0.01mg/ml DVDMS solution (0.1ml) is prepared for skin test followed by 0.04 mg/ml DVDMS solution intravenous injection(0.2mg/kg).The target atherosclerotic lesions are marked on the corresponding skin with ultrasound guidance and underwent ultrasound exposure after 4 hours incubation. The therapeutic ultrasonic transducer is fixed to the marked skin site for 15 min of each lesion. Ultrasound parameters included intensity of 2.1W/cm2 for each lesion, resonance frequency: 1.0 MHz and duty factor: 30%.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ye Tian, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Harbin Medical University

Other Identifiers

Ye Tian PVAT

Identifier Type: -

Identifier Source: org_study_id