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 @ 3:55 PM
Ignite Modification Date:
2025-12-24 @ 3:55 PM
NCT ID:
NCT02632292
Eligibility Criteria:
Clinical inclusion criteria:
* Age ≥18 years
* DM type I or II based on the definitions of the American Diabetes Association
* Angiographically proven CAD
* Angina pectoris, equivalent symptoms, and/or positive stress test, and/or instantaneous flow reserve ≤0.86, and/or fractional flow reserve ≤0.80
* Negative pregnancy test in women with childbearing potential
Angiographic inclusion criteria:
* De-novo lesion in at least one native coronary artery
* Luminal diameter reduction 50-99% assessed by visual estimation
* Target reference vessel diameter 2.5 - 4.0 mm
Clinical exclusion criteria:
* Limited long-term prognosis with a life-expectancy \<12 months
* Contraindications to antiplatelet therapy
* Known allergy against cobalt chrome, everolimus, or polylactic acid
Angiographic exclusion criteria:
* Target lesion located in the left main trunk
* Severe calcification of the target lesion as determined by angiography
* In-stent restenosis
* Bifurcation lesion with planned two-stent strategy
* Chronic total occlusion
* Indication for CABG
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02632292
Study Brief:
Protocol Section:
NCT02632292