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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT05292651
Eligibility Criteria:
Inclusion Criteria:
1. Stable angina patients or acute coronary syndrome patients with bystander stable coronary artery disease
2. With one or more significant epicardial stenosis in native coronary arteries suitable for direct stenting, according to the judgement of treating operator.
The use of fractional flow reserve (FFR) or resting indices like iFR and RFR to assess lesion severity is encouraged.
3. Subject must be at least 18 years of age
4. Written consent to participate in the study
Exclusion Criteria:
1. Lesions not suitable for direct stenting, like (sub)-total stenosis, severely calcified lesions
2. Culprit lesions of acute coronary syndrome cannot be randomized to the trial. After successful treatment of the ACS culprit lesion, patients however can be randomized in the trial in case of remaining stable non-culprit lesions that thought to be stented directly of during a staged procedure.
3. Lesions not suitable for OCT catheter delivery and imaging, e.g. left main or ostial right coronary artery stenosis, lesions in coronary bypass grafts or tortuous anatomy
4. Treatment for in-stent restenosis
5. Bifurcation lesions in which a two-stent technique or a proximal postdilatation is planned.
6. Treatment of coronary artery bypass grafts
7. Creatine Clearance ≤ 30 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR)
8. Known hypersensitivity or allergy for cobalt chromium
9. Known comorbidity associated with a life expectancy \< 1 year
10. Unable to understand and follow study-related instructions or unable to comply with study protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT05292651
Study Brief:
Protocol Section:
NCT05292651