Sonodynamic Therapy on Patients With Femoropopliteal PAD and Claudication

NCT03318484 | Withdrawn Phase 1

• 1 other identifier: Ye Tian
• 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 atherosclerotic plaques inflammation and increasing peak walking time (PWT) among peripheral artery disease (PAD) patients with symptom of intermittent claudication.

Conditions

Peripheral Arterial Disease; Atherosclerosis; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

• PWT change, mins

  Change from baseline peak walking time (PWT) at 6 months is assessed by graded treadmill test (Gardner protocol). The patient continues the test until walking can no longer be tolerated because of claudication symptoms.

  Measured at baseline, 1, 3 and 6 months.

• MDS TBR change, (%)

  Change from baseline most disease segments (MDS) at 3 months is assessed by 18FDG-PET imaging. Uptake of FDG by the common and superficial femoral artery is expressed as the target, vessel wall to background, lumen ratio (TBR). The mean max MDS TBR is defined as the arterial segment centered on the slice of artery demonstrating the highest FDG uptake at baseline within the index vessel, and calculated as a mean of maximum TBR values derived from three contiguous axial segments.

  Measured at baseline, 1 and 3 months.

Secondary Outcomes (12)

• COT change, mins

  Measured at baseline, 1, 3, and 6 months.

• AS TBR change, (%)

  Measured at baseline, 1 and 3 months.

• WV TBR change, (%)

  Measured at baseline, 1 and 3 months.

• Serum inflammation cytokine level

  Measured at baseline, 1, 3, and 6 months.

• Pre-exercise ABI

  Measured at baseline, 1, 3, and 6 months.

Study Arms (2)

Optimal Medical Care

ACTIVE COMPARATOR

Optimal medical care (OMC) only is 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.

Drug: Optimal Medical Care

Optimal Medical Care and SDT

EXPERIMENTAL

OMC and sonodynamic therapy (SDT) are administrated in this arm.

Drug: Optimal Medical Care; Combination Product: Sonodynamic therapy

Interventions

Optimal Medical Care DRUG

Aspirin 100mg once a day, Atorvastatin 20mg once a day and Antihypertensive Agents if necessary.

Optimal Medical Care; Optimal Medical Care and SDT

Sonodynamic therapy COMBINATION_PRODUCT

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 for 15min of each lesion. Ultrasound parameters included intensity of 1.8W/cm2 for femoral lesions, resonance frequency: 1.0 MHz and duty factor: 30%.

Optimal Medical Care and SDT

Eligibility Criteria

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

You may qualify if:

• 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)
• Aged ≥40 years
• Resting ABI \< 0.9 or ABI decreases \> 0.15 after treadmill test regardless of the ABI at rest
• Presence of significant stenosis but not occlusion of femoropopliteal arteries including the common femoral artery, superficial femoral artery and popliteal artery as determined by: Duplex ultrasound imaging OR lower extremity computed Tomography Angiography (CTA) OR lower extremity magnetic resonance angiography (MRA) OR lower extremity catheter-based contrast arteriography. Each of these noninvasive and invasive anatomic assessments will identify patients with at least a 50% stenosis in the affected segment
• 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:

• Critical limb ischemia or other comorbid conditions that limit walking ability (claudication must be the consistent primary exercise limitation)
• Inability to complete treadmill testing per protocol requirements
• Two treadmill tests are completed at baseline to confirm reproducibility of results; those who deviates \>25% are excluded
• Severe aorto-iliac arteries stenosis or occlusion documented by noninvasive and invasive anatomic assessments
• Allergic to DVDMS
• Diagnosis of porphyria
• Pregnant women and nursing mothers
• Contraindications of PET/CT
• Concurrent enrollment in another clinical trial
• Presence of any clinical condition that in the opinion of the principal Investigator or the sponsor makes the patient not suitable to participate in the trial

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead
• Harbin Medical University: collaborator

MeSH Terms

Conditions

Peripheral Arterial Disease; Atherosclerosis; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Peripheral Vascular Diseases

Study Officials

• YE TIAN, MD, PhD

  First Affiliated Hospital of Harbin Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 24, 2017
• Study Start: November 1, 2017
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: August 23, 2021

Record last verified: 2017-10