Clinical trial NCT03967730: Sonodynamic Therapy in the Treatment of Perivascular Adipose Tissue on Patients With PAD and Claudication
Official title: Sonodynamic Therapy in the Treatment of Perivascular Adipose Tissue on Patients With PAD and Claudication
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Peripheral Arterial Disease
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in PVAT Density, as assessed by CTA
timeFrame: Measured at Baseline, 1, 3 months
Secondary outcomes:
measure: PWT change, mins
timeFrame: Measured at Baseline, 1, 3 months
measure: Change in peak flow velocity, as assessed by doppler ultrasound
timeFrame: Measured at Baseline, 1, 3 months
measure: Incidence of adverse events
timeFrame: Measured at Baseline, 1, 3 months
measure: Plasma adipokines level
timeFrame: Measured at Baseline, 1, 3 months
measure: Plasma inflammation cytokine level
timeFrame: Measured at Baseline, 1, 3 months
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital of Harbin Medical University
name: Ye Tian, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References: