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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00776568
Study type Interventional
Source Universal Research Group
Contact
Status Active, not recruiting
Phase Phase 3
Start date February 2008

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