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

NCT03967730 | Withdrawn Phase 1

• 1 other identifier: Ye Tian PVAT
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Change in PVAT Density, as assessed by CTA

  The changes in CT attenuation (HU) of perivascular adipose tissue(PVAT) as assessed by CTA.

  Measured at Baseline, 1, 3 months

Secondary Outcomes (5)

• PWT change, mins

  Measured at Baseline, 1, 3 months

• Change in peak flow velocity, as assessed by doppler ultrasound

  Measured at Baseline, 1, 3 months

• Incidence of adverse events

  Measured at Baseline, 1, 3 months

• Plasma adipokines level

  Measured at Baseline, 1, 3 months

• Plasma inflammation cytokine level

  Measured at Baseline, 1, 3 months

Study Arms (1)

Sonodynamic therapy(SDT)

EXPERIMENTAL

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

Combination Product: Sonodynamic therapy(SDT)

Interventions

Sonodynamic therapy(SDT) 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%.

Sonodynamic therapy(SDT)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Ye Tian, MD,PHD

  First Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: May 30, 2019
• Study Start: June 20, 2019
• Primary Completion: May 30, 2020
• Study Completion: May 30, 2020
• Last Updated: April 15, 2021

Record last verified: 2019-05