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 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT02502851
Eligibility Criteria:
Inclusion Criteria:
1. Clinical inclusion criteria
* Age above 18 years and consentable
* Angiographically proven coronary artery disease
* Anginal symptoms and/or reproducible ischemia in the target area by ECG, functional stress testing or fractional flow reserve
* Written informed consent
2. Angiographic inclusion criteria
* De-novo lesion in a native coronary artery
* Target reference vessel diameter between 2.25 and 4.0 mm by visual estimation
* Luminal diameter reduction of 50-100% by visual estimation
* Severe calcification of the target lesion
Exclusion Criteria:
1. Clinical exclusion criteria
* Myocardial infarction (within 1 week)
* Decompensated heart failure
* Limited long term prognosis due to other conditions
2. Angiographic exclusion criteria
* Target lesion is in a coronary artery bypass graft
* Target lesion is an in-stent restenosis
* Target vessel thrombus
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02502851
Study Brief:
Protocol Section:
NCT02502851