Overview

Sonodynamic Therapy on Patients With Femoropopliteal PAD and Claudication

Status:
Withdrawn

Trial end date:
2019-11-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

First Affiliated Hospital of Harbin Medical University

Collaborator:

Harbin Medical University

Criteria

Inclusion Criteria:

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 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

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 Criteria:

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. Allergic to DVDMS

6. Diagnosis of porphyria

7. Pregnant women and nursing mothers

8. Contraindications of PET/CT

9. Concurrent enrollment in another clinical trial

10. 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