Status:
COMPLETED
Sonodynamic Therapy Manipulates Atherosclerosis Regression Trial on Patients With PAD and Claudication
Lead Sponsor:
First Affiliated Hospital of Harbin Medical University
Conditions:
Peripheral Arterial Disease
Atherosclerosis
Eligibility:
All Genders
40+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 periphera...
Detailed Description
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 sym...
Eligibility Criteria
Inclusion
- 1\. 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)
- 2\. Aged ≥40 years
- 3\. Resting ABI \< 0.9 or ABI decreases \> 0.15 after treadmill test regardless of the ABI at rest
- 4\. Presence of atherosclerotic plaque in 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
- 5\. 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
- 6\. Written informed consent
Exclusion
- 1\. Critical limb ischemia or other comorbid conditions that limit walking ability (claudication must be the consistent primary exercise limitation)
- 2\. Inability to complete treadmill testing per protocol requirements
- 3\. Two treadmill tests are completed at baseline to confirm reproducibility of results; those who deviates \>25% are excluded
- 4\. Severe aorto-iliac arteries stenosis or occlusion documented by noninvasive and invasive anatomic assessments
- 5\. Active systemic inflammatory disease or have an infectious disease within 1 month prior to enrollment
- 6\. Allergic to DVDMS
- 7\. Diagnosis of porphyria
- 8\. Pregnant women and nursing mothers
- 9\. Contraindications of PET/CT
- 10\. Concurrent enrollment in another clinical trial
- 11\. Presence of any clinical condition that in the opinion of the principal investigator makes the patient not suitable to participate in the trial
Key Trial Info
Start Date :
March 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2019
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03457662
Start Date
March 15 2018
End Date
April 11 2019
Last Update
August 21 2024
Active Locations (1)
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1
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150000