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 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT01202058
Eligibility Criteria:
Inclusion Criteria:
* Subject has atherosclerotic coronary artery disease with an indication for stent implantation;
* Target lesion(s) with a diameter stenosis of minimally 50% (visual estimate) OR a functional study documenting the hemodynamic relevance of the target lesion(s);
* All target lesion(s) require treatment with stents having diameters from 2.5mm to 3.5mm (visual estimate);
* Subject is ≥18 years of age;
* Subject must sign Ethics Committee approved informed consent prior to undergoing any study specific procedure;
* Subject must be willing and able to comply with specified follow-up schedule.
Exclusion Criteria:
* Planned medical procedures or concomitant disease requiring modification of DAPT regimen within 6 months of enrollment into this study;
* Women of childbearing potential without negative pregnancy test within 7 days before enrollment OR women who do not agree to remain on birth control until angiographic follow-up at 13 months if applicable OR lactating women. For women of childbearing potential, requiring an acute, non-elective procedure, a verbal confirmation of non-pregnancy and birth control is sufficient;
* Currently participating in an investigational study that has not completed the primary endpoint or that clinically interferes with the study endpoints.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01202058
Study Brief:
Protocol Section:
NCT01202058