Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT01219218
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01219218
Study Brief:
Protocol Section:
NCT01219218