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:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-24 @ 4:59 PM
NCT ID:
NCT03742050
Eligibility Criteria:
Inclusion Criteria:
ORBITA-2 will enrol patients who meet all 3 of the following criteria:
1. Angina or angina-equivalent symptoms
2. Anatomical evidence of significant coronary stenosis in at least one vessel, either: a. Invasive diagnostic coronary angiogram indicating ≥ 70% stenosis b. CT coronary angiography indicating ≥ 90% stenosis
3. Evidence of ischaemia, arising from at least one of the following options:
1. Positive dobutamine stress echocardiography
2. Positive cardiac MRI perfusion scan
3. Positive nuclear medicine myocardial perfusion scan
4. Invasive pressure wire assessment suggestive of ischaemia, as judged by the interventional cardiologist, at the time of diagnostic angiogram or research angiogram
Exclusion Criteria:
1. Age younger than 18
2. Age older than 85
3. Recent acute coronary event
4. Previous coronary artery bypass graft surgery
5. Significant left main stem coronary disease
6. Chronic total occlusion in the target vessel
7. Contraindication to percutaneous coronary intervention or drug-eluting stent implantation
8. Contraindication to antiplatelet therapy
9. Severe valvular disease
10. Severe LV systolic impairment
11. Severe respiratory disease
12. Life expectancy less than 2 years, pregnancy, unable to consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03742050
Study Brief:
Protocol Section:
NCT03742050