Shockwave Treatment for Advanced Angina in Maastricht (SWAAM)
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ClinicalTrials.gov Identifier: NCT01361659
Recruitment Status : Unknown
Verified July 2011 by Maastricht University Medical Center. Recruitment status was: Recruiting
There is an increasing number of patients with a coronary anatomy that does not allow additional revascularization procedures, while the patients suffer from angina pectoris at rest or at minimal exercise levels despite optimised medical therapy. There is a lack of therapeutic options for this group of so called "no-option patients". Goal of the project is to implement the shockwave therapy for no-option coronary artery disease patients and to evaluate its potential benefit on regional myocardial perfusion, on regional myocardial function and on the potential improvement in symptoms and quality of life.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Chronic angina pectoris CCS (Canadian Cardiological Society) III or IV with documented reversible ischemia and/or hibernation.
Patients demonstrates exercise tolerance test (ETT) duration < 10 minutes on a modified Bruce protocol
No possibility of traditional revascularization by coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI)
Contraindication for Magnetic resonance imaging (MRI) (pacemaker, metallic prostheses)
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 Extracorporeal Shock Wave Therapy (ESWT) machine for neovascularization of a competitor company within 3 months of entry into the study.
Patients who are unwilling or unable to cooperate with the study procedure.