Efficacy of Extracorporeal Shockwave Myocardial Revascularization (ANGEL)

This is an interventional treatment trial for Refractory Angina Pectoris Read More

Inclusion Criteria:

• Patient with a signed Informed Consent Form.
• Patient's current and past medical condition and status be assessed using previous medical history, complete physical examination and the physicians (principle investigator's) medical opinion.
• Patient is diagnosed with chronic angina pectoris for at least 6 weeks. Diagnosis is based on medical history, complete physical examination, and core labs.
• Patients who no longer receive benefit from additional revascularization procedures (i.e. CABG or Angioplasty). Certification will be made by Heart Team.
• Patient demonstrates Exercise Tolerance Time (ETT) duration < 10 minutes on Modified Bruce protocol.
• Patient had at least one documented myocardial segment with reversible ischemia.
• Patient is under optimum medical therapy for angina for at least 6 weeks. The optimal treatment plan is tailored to a person's age, the presence of other medical conditions, lifestyle, medication side effects, etc. Medical therapies for stable angina include ACE-inhibitors, Nitrates, Beta Blockers and Calcium Channel Blockers, trimetazidine, ivabradin. Combination of any of 3 above mentioned drugs will be considered as optimum medical therapy.
• Patient has an echocardiographic acoustic window to the target area in the myocardium utilizing one of the following views: apical 2 chamber view (2CH), apical 4 chamber view (4CH), modified parasternal long axis view (LAX) and parasternal short axis view (SAX).

Exclusion Criteria:

• Patient who will substantially benefit from additional revascularization procedures such as additional CABG or angioplasty therapies. This determination will be made and certified by the Heart Team.
• Patient has active endocarditis, myocarditis or pericarditis.
• Patient with moderately severe or severe valvular disease.
• Patient with known intraventricular thrombus.
• Patients who have active or non-active implantables, such as pacemakers, defibrillators, abandoned leads, or electrodes.
• Patient for who shock waves applied over any implanted device that releases substances or medications to the periphery (such as insulin pumps).
• Patient is pregnant.
• Patient with severe chronic lung disease (emphysema, pulmonary fibrosis) with difficult access to ultrasonic acoustic window.
• Patients for who shock waves applied over the area of healing fracture.
• Patients for who shock waves applied over the area of bone growth.
• Patients for who shock waves applied to the area of malignancy.
• Prior invasive malignancy, except non-melanomatous skin cancer or other malignancies with a documented disease-free survival for a minimum of 5 years.
• By the physician decision there is underlying concomitant disease or circumstance what may negatively influence the management of the patient.