Angina Pectoris Clinical Trial
Official title:
Extracorporeal Shock Wave Therapy (ESWT) for the Treatment of Refractory Angina Pectoris
The purpose of this study is to determine that extracorporeal shock wave therapy (ESWT) is safe and effective for the treatment of refractory angina pectoris.
Patients with advanced CAD frequently have limited symptoms with recurrent angina, angina at
low work thresholds, breathlessness, and other debilitating conditions. These patients have
often been through several "re-do" coronary bypass procedures and multiple percutaneous
coronary interventions.
Surgical and interventional options for these patients typically have been exhausted or will
result in only partial revascularization. Therefore, therapy remains limited to the use of
multiple anti-anginal medications, reduced activity, exertion, and stress level, and
significant alteration and limitation of lifestyle.
The goal of this emerging approach is to therapeutically induce the growth and development
of new vasculature in zones of severe ischemia in the myocardium, with the hope that new
capillaries and arterioles generated will connect to remnant existing vasculature. These
neovessels are viewed to act as collaterals, perfusing ischemic territories unapproachable
by macro procedures such as PCI and/or CABG.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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