A Phase 1/2 interventional study of OMC and pseudo-SDT and OMC and SDT in Peripheral Arterial Disease, Atherosclerosis and Cardiovascular Diseases, sponsored by First Affiliated Hospital of Harbin Medical University. Completed at 1 site in China. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by First Affiliated Hospital of Harbin Medical University · Phase 1/2, Interventional, and Treatment
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.
Exclusion Criteria:
Optimal medical care (OMC) and pseudo-SDT are administrated in this arm. OMC is established according to the standards established by the 2016 ACC-AHA Guidelines for the Management of Patients with Peripheral Artery Disease in order to promote best practices for risk factor management.
Combination Product: OMC and pseudo-SDT
OMC and SDT are administrated in this arm.
Combination Product: OMC and SDT
OMC is established according to the 2016 ACC-AHA Guidelines for the Management of Patients with PAD. Pseudo-SDT combines saline injection and obstructed ultrasound exposure on targeted lesions to simulate real SDT progression.
OMC is established according to the 2016 ACC-AHA Guidelines for the Management of Patients with PAD. SDT treatment is the combination of sonosensitizer administration and target atherosclerotic lesions ultrasound exposure. 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 of each lesion.
Change in MDS TBR
The primary efficacy endpoint is the change of target-to-background ratio (TBR) within the most diseased segment (MDS) of index-leg artery at 30-day follow-up after treatment, defined as ratio of the standardized uptake value (SUV) in artery wall to background venous activity within the MDS of index- leg artery assessed by PET/CT.
Time frame: Measured at baseline, 1month.
AS TBR change, (%)
Change from baseline to 30-day in active slice (AS) assessed by PET/CT. The mean max AS TBR is defined as average mean maximal TBR of only slices with TBR \>1.6 from index-leg at baseline.
Time frame: Measured at baseline, 1month.
WV TBR change, (%)
Change from baseline to 30-day in whole vessel (WV) TBR assessed by PET/CT. The mean max WV TBR is defined as a single whole vessel average mean maximal TBR of all the slices that compose the index vessel.
Time frame: Measured at baseline, 1month.
PWT change, s
Change 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.
Time frame: Measured at baseline, 1month.
COT change, s
Change from baseline claudication onset time (COT) at 1 month is assessed by graded treadmill test (Gardner protocol). The patient continues the test until calf muscle discomfort is first noticed.
Time frame: Measured at baseline, 1month.
Pre-exercise ABI
Ankle-Brachial Index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure of the upper arm. Pre- exercise ABI is collected routinely with the patient supine immediately prior to a treadmill test.
Time frame: Measured at baseline, 1month.
Diameter stenosis, (%)
Estimation of the maximum diameter stenosis of the affected segments by doppler ultrasound.
Time frame: Measured at baseline, 1month.
WIQ score
The Walking Impairment Questionnaire (WIQ) assesses the severity of the subjective walking impairment on distance, speed, and stair climbing scales. It is administered as a self report. Range: Minimum score is 0.2, maximum 100.
Time frame: Measured at baseline, 1month.
SF-36 score
The patient reported SF-36 data assesses subjective physical limitations, leg symptoms, social function, treatment satisfaction, and quality of life. It is administered as a self report. Higher scores are indicative of better outcome. The summary scores is compiled by taking the mean of five subscales generated from the original questions. Range: Minimum score is 11.1, maximum 85.
Time frame: Measured at baseline, 1month.
The number and percentage of mildly/severely calcified sites
According to the Hounsfield unit calcium density of PET/CT, the arterial sites were divided into 3 groups: non-calcified sites (\< 130 HU), mildly calcified sites (130-399 HU) and severely calcified sites (≥400 HU). The exploratory endpoints is the number and percentage of mildly/severely calcified sites.
Time frame: Measured at baseline, 1month.
The CT values of mildly and severely calcified sites
The exploratory endpoints is the CT values of mildly and severely calcified sites.
Time frame: Measured at baseline, 1month.
The TBR values of mildly and severely calcified sites
The exploratory endpoints is the TBR values of mildly and severely calcified sites.
Time frame: Measured at baseline, 1month.
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First Affiliated Hospital of Harbin Medical University