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 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT01574534
Eligibility Criteria:
Inclusion Criteria:
* Angina pectoris Canadian Cardiovascular Society (CCS) 2 to 4 or silent ischemia as assessed by stress echocardiography, stress cardiac magnetic resonance, myocardial perfusion scintigraphy, or fractional flow reserve
* PCI of de-novo stenosis in vessels ≥2.0 to \<3.0 mm in diameter irrespective of the indication (concomitant PCI of a vessel ≥3.0 mm in diameter is permitted if the stenosis is located in a coronary artery other than the culprit vessel)
* No flow-limiting dissection (TIMI ≤2) or residual stenosis \>30% after initial dilatation with a standard or non-compliant balloon, as assessed by the physician in charge
* Written informed consent
Exclusion Criteria:
* Concomitant large-diameter PCI in the same coronary artery (LAD, Ramus circumflexus (RCX), RCA)
* PCI of instent-restenosis (culprit lesion)
* Life expectancy \<12 months
* Pregnancy
* Enrolled in another coronary intervention study
* Unable to give informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01574534
Study Brief:
Protocol Section:
NCT01574534