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 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT03487432
Eligibility Criteria:
Inclusion Criteria:
* Age above 18 years and consentable;
* Persistent angina symptoms despite optimal medical therapy and/or evidence of inducible ischemia;
* Angiographically-proven coronary artery disease;
* De novo lesion in a native coronary artery;
* Target reference vessel diameter between 2.25 and 4.00 mm by visual estimation;
* Calcification of the target lesion as determined by angiography (grade 3);
* Unsuccessful lesion preparation (\<30% reduction of baseline diameter stenosis) with conventional NC balloon angioplasty
* Written informed consent.
Exclusion Criteria:
* Myocardial infarction (within 1 week);
* Limited long-term prognosis due to other conditions;
* Target lesion is in a coronary artery bypass graft;
* Target lesion is an in-stent restenosis;
* Target lesion is aorto-ostial;
* Target vessel thrombus.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03487432
Study Brief:
Protocol Section:
NCT03487432