Sonodynamic Therapy on Patients With Femoropopliteal PAD and Claudication

H

Harbin Medical University

Status and phase

Withdrawn
Phase 2
Phase 1

Conditions

Cardiovascular Diseases
Peripheral Arterial Disease
Atherosclerosis

Treatments

Drug: Optimal Medical Care
Combination Product: Sonodynamic therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03318484
Ye Tian

Details and patient eligibility

About

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.

Full description

Atherosclerotic lower extremity PAD affects more than 20 million people in the world. PAD is associated with a major decline in 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. The aim of this trial is to test the hypothesis that SDT improves PWT by inhibiting atherosclerotic plaques inflammation in femoropopliteal arteries PAD patients compared to optimal medical care (OMC) within 6 month. An estimated 80 eligible patients will be randomly divided into tow groups: OMC and SDT combined with OMC. Recruitment will be performed over 6 months and patients will be followed for 6 months; the anticipated total study duration will be 2 years. Finally, this trial investigate the safety and efficacy of SDT in PAD patients with intermittent claudication and explore new end-points to evaluate therapeutic effects using PET-CT imaging as well as traditional endpoints.

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 2 patient groups

Optimal Medical Care
Active Comparator group
Description:
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.
Treatment:
Drug: Optimal Medical Care
Optimal Medical Care and SDT
Experimental group
Description:
OMC and sonodynamic therapy (SDT) are administrated in this arm.
Treatment:
Combination Product: Sonodynamic therapy
Drug: Optimal Medical Care

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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