Extracorporeal Shockwave Therapy for the Treatment of Refractory Angina Pectoris

Phase 2

Completed

• Conditions: Refractory Angina Pectoris

• Registration Number: NCT00662727
• Lead Sponsor: Medispec

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 symptoms of patients with refractory angina not amenable to revascularization with angioplasty or bypass surgery.

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 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- SPECT testing to identify the ischemic areas. Following that, the same area is localized by the ultra-sound device and the shockwaves are focused to the ischemic area. Several treatments are required for optimal results.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2008-04-14
• Study First Submitted QC: 2008-04-18
• Study First Posted: 2008-04-21
• Primary Completion: 2012-06
• Study Completion: 2012-11
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-17
• Last Update Posted: 2013-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total Exercise Time	6 months

Secondary Outcome Measures

Name	Time	Method
Change in SPECT	6 months
Change in AP-CCS	6 months

Trial Locations

Locations (1)

Hadassah-Hebrew University Medical Center; 🇮🇱 Jerusalem, Israel