Sonodynamic Therapy in the Treatment of Carotid Atherosclerosis
Sonodynamic Therapy in the Treatment of Carotid Atherosclerosis
Sonodynamic therapy (SDT) is a new treatment for carotid atherosclerotic plaque. The purpose
 of this study is to evaluate the safety and initial effectiveness of this technique.
Carotid atherosclerotic plaque is an important cause of ischemic stroke. Treatments for
 patients with carotid plaque include lifestyle changes, medical management(such as control of
 hyperlipidemia, hypertension, and diabetes) and carotid revascularization(carotid
 endarterectomy or carotid artery stenting). Studies have suggested that plaque morphology and
 composition are important determinants of plaque stability, using serial MR imaging of the
 carotid artery allowed observation of changes in plaque composition. Contrast enhanced
 ultrasound (CEUS) is a well accepted technique for detection of intraplaque
 neovascularization(IPN) in carotid atherosclerotic disease. The purpose of this trial is to
 evaluate the safety and initial effectiveness of SDT. The SDT can induce macrophage
 elimination and inhibit matrix degradation, which will promote plaque lipid depletion,
 inflammation level decrease and changes in other plaque tissue components, leading to plaque
 stabilization and reduction.
Inclusion Criteria:

 -  Age 18- 80 years

 -  Carotid artery with 30%~70% stenosis by ultrasound and plaque thickness>2.5mm

 -  Patients without transient ischemic attack, minor stroke or amaurosis fugax within 6
 months

 -  Patients' LDL-c level below 100 mg/dL(2.6mmol/L), well-controlled blood
 pressure(systolic BP<140 and diastolic BP<90 under resting conditions) and
 diabetes(HbA1c<7%)

 -  Written informed consent

 Exclusion Criteria:

 -  Non-atherosclerotic carotid artery stenosis

 -  Contraindication to MRI( uses pacemaker, has metallic implants, claustrophobia)

 -  Acute MI, acute coronary syndrome or stroke within 4 weeks prior to visit

 -  Severe cerebral artery stenosis, atrial fibrillation or MRI detected thrombosis that
 would cause stroke

 -  Previous significant adverse reaction to a statin

 -  Systemic disorders such as hepatic, renal, hematologic, and malignant disease

 -  Medical history that might limit the individual's ability to take trial treatments for
 the duration of the study

 -  Allergic to DVDMS or sonovue

 -  Diagnosis of porphyria

 -  Pregnant women and nursing mothers

 -  History of bilateral carotid endarterectomy or has immediate plans for carotid
 endarterectomy

 -  Patient who is attending other clinical trial