Refractory Angina Pectoris Clinical Trial
Official title:
Randomized, Placebo Controlled, Double Blind Clinical Trial Evaluating the Treatment of Patients With Refractory Angina Pectoris With Low Intensity Extracorporeal Shockwave Therapy Device
Low intensity shockwaves have been proven in animal studies to induce local growth of new
blood vessels from existing ones.
The hypothesis of this study is that shockwave therapy could improve the symptoms of
patients with refractory angina not amenable to revascularization with angioplasty or bypass
surgery.
Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to myocardial
ischemic tissue. Shockwaves are created by a special generator and are focused using a
shockwave applicator device. The treatment is guided by standard echocardiography equipment.
The shockwaves are delivered in synchronization with Patient R-wave to avoid arrhythmias.
The treatment is painless.
At first, the patient undergoes Stress-Echocardiography testing to identify the hypokinetic
areas (ischemic areas). Following that, the ischemic areas sre treated with shockwaves.
Several treatments are required for optimal results.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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