Status:
COMPLETED
Extracorporeal Shockwave Therapy for the Treatment of Refractory Angina Pectoris
Lead Sponsor:
Medispec
Collaborating Sponsors:
Hadassah Medical Organization
Conditions:
Refractory Angina Pectoris
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 sy...
Detailed Description
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 dev...
Eligibility Criteria
Inclusion
- Diagnosed with chronic stable angina pectoris.
- Documented myocardial segments with reversible ischemia
- AP CCS class of III-IV.
- Stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment.
- Exercise tolerance time \< 10 min (modified Bruce)
- Two ETT tests results (within two weeks) averaging no more than 25% of their mean
- Documented epicardial coronary artery disease not amenable to angioplasty or CABG.
- Signed an IRB approved informed consent form.
- Life expectancy of \>12 months.
Exclusion
- Intraventricular thrombus
- Malignancy in the area of treatment
- Severe COPD
- No smoking during the study procedure
- MI less \<3 months prior to treatment
- Severe Valvular disease
- Child bearing potential
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00662727
Start Date
January 1 2007
End Date
November 1 2012
Last Update
February 20 2013
Active Locations (1)
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1
Hadassah-Hebrew University Medical Center
Jerusalem, Israel