Extracorporeal Shockwave Therapy for the Treatment of Refractory Angina Pectoris

Randomized, Placebo Controlled, Double Blind Clinical Trial Evaluating the Treatment of Patients With Refractory Angina Pectoris With Low Intensity Extracorporeal Shockwave Therapy Device

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00662727

Enrollment

Registered

2008-04-21

Start date

2007-01-31

Completion date

2012-11-30

Last updated

2013-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory Angina Pectoris

Keywords

Extracorporeal Shockwave Therapy, Myocardial Ischemia, Refractory Angina

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.

Interventions

DEVICECardiac Extracorporeal Shockwave Therapy generator (Cardiospec)

Energy Density - 0.09 mJ/mm2

DEVICEPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Total Exercise Time	6 months

Secondary

Measure	Time frame
Change in SPECT	6 months
Change in AP-CCS	6 months

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026