Efficacy of Extracorporeal Shockwave Myocardial Revascularization Therapy in Patients With Stable Angina Pectoris

Inclusion Criteria:

• Male and female patients (females of childbearing potential must be using adequatecontraceptive precautions such as implants, injectables, combined oral contraceptives,intrauterine devices, sexual abstinence or vasectomized partner).

• Patients aged ≥ 18 years.

• Patients with coronary artery disease confirmed by angiography, prior MI, priorrevascularization (PCI, CABG) and with exercise angina not controlled by the optimalmedical therapy.

• Patient should be on a stable dosage of medication used to treat angina for at least 4weeks prior to enrollment.

• ST-segment depression ≥ 1mm during exercise ECG.

• Able and willing to sign informed consent and to comply with study procedures.

• Written informed consent prior to enrolment into the study.

Exclusion Criteria:

• Angina at rest.

• ECG abnormalities at rest (left bundle-branch block, resting ST-segment depression ≥ 1mm, digoxin therapy, WPW-syndrome).

• Planned coronary intervention or CABG within 6 months.

• Heart failure (class III or IV NYHA).

• Moderate-severe hypertension (SBP>160 mmHg and/or DBP>100 mmHg).

• Hypotension (SBP<100 mmHg).

• Acute coronary syndrome or coronary revascularization procedure within the prior 3months before enrolment.

• Females who are pregnant or nursing.

• Any clinically relevant hematological or biochemical abnormality on routine screening,according to Investigator's judgment.

• Severe concurrent pathology, including terminal illness (cancer, AIDS, etc.).

• Renal impairment defined as Creatinine >150 mcmol/l.

• Mild, moderate or severe hepatic impairment or hepatic insufficiency defined as: SGOTor SGPT > 3 times greater than normal upper limit or total serum bilirubin > 1.5 timesgreater than normal upper limit

• Existing contraindications for exercise testing (e.g. acute myocarditis orpericarditis, DVT, severe aortic stenosis)

• Dementia, psychosis, alcoholism (>350 g ethanol/week) or chronic abuse of medicines,drugs or psychoactive substances.

• Conditions which in the Investigator's opinion may interfere with the study'sexecution or due to which the patient should not participate for safety reasons.

• Risk of low patient cooperation.

• Inability or unwillingness to issue the informed consent.

• Patient is simultaneously participating in another device or drug study, or hasparticipated in any clinical trial involving an experimental device or drug, includingother drugs or devices enhancing cardiac neovascularization, or any cardiac shock wavetherapy machine of a competitor company within 3 months of entry into the study.