Extracorporeal Shockwave Therapy for the Treatment of Advanced Angina Pectoris

Medispec

Status and phase

Completed

Phase 1

Conditions

Refractory Angina Pectoris

Treatments

Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01219218

ESMR-AZM-NL

Details and patient eligibility

About

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.

Full 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 treatment session (9 in total, spread over 9 weeks) are required for optimal results.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient is diagnosed with chronic stable angina pectoris, for a period of at least 3 months. Diagnosis is based on medical history, complete physical evaluation.
Patient has documented myocardial segments with reversible ischemia.
Patient is classified in AP CCS of III-IV.
Patient should be on a stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment.
Patient demonstrates exercise tolerance capacity of no higher than 125 W on a modified Bruce treadmill exercise test until presence of clinical symptoms (i.e. angina, ST-depression).
Patient demonstrates exercise tolerance time and stability averaging no more than 25% of each other (the tests will be performed within two weeks and at least a day different between the two).
Patient has documented epicardial coronary artery disease not amenable to angioplasty or CABG.
Patient has signed an IRB approved informed consent form.
Patient's condition should be stable and should have a life expectancy of >12 months. Patient's current and past medical condition and status will be assessed using previous medical history, physical evaluation, and the physicians (principle investigator's) medical opinion.

Exclusion criteria

Patient is pregnant
Patient has chronic lung disease including emphysema and pulmonary fibrosis.
Patient has active endocarditis, myocarditis or pericarditis.
Patient is simultaneously participating in another device or drug study, or has participated in any clinical trial involving an experimental device or drug, including other drugs or devices enhancing cardiac neovascularization, or any ESWT machine of a competitor company within 3 months of entry into the study.
Patients who are unwilling or unable to cooperate with study procedure