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 @ 12:05 PM
Ignite Modification Date:
2025-12-24 @ 12:05 PM
NCT ID:
NCT05599061
Eligibility Criteria:
Inclusion Criteria:
* Patients \> 18 years.
* Successful revascularization of the culprit lesion in patients undergoing coronary angiography due to ST-segment elevation (\> 1mm in \> 2 contiguous leads, new left bundle branch block, or true posterior MI with ST depression of \>1mm in \>2 contiguous anterior leads) in the first 72 hours of the symptom's onset.
* Multivessel coronary disease with non-culprit lesions located in different vessels than the culprit lesion and ranging from 40 to 69% of DS (visual estimated diameter stenosis ) by visual estimate planned for FFR-guided revascularization in staged procedure (\>24 hours and \<60 days after PCI of the culprit lesion).
* Non-culprit lesions should be suitable for functional assessment with pressure wire and OCT catheter and should be suitable to be treated with a single 2.0 to 4.5 mm EES (everolimus-eluting stent ).
* Subject agrees to not participate in any other clinical trial study for a period of 4 years following the inclusion in the study.
* Informed consent signed.
Exclusion Criteria:
* Inability to provide informed consent.
* Female of childbearing potential (age \<50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy.
* Known intolerance to aspirin, heparin, everolimus, contrast material.
* Unresolved mechanical complication or cardiogenic shock at the staged procedure.
* Non-culprit study lesions located in the left main coronary artery or in coronary vessels with prior coronary revascularization (PCI or by-pass) or with distal vessel occlusion.
* Patients with long, bifurcated, severely angulated or severely calcified non-culprit study lesions non suitable to be treated with a single EES implantation.
* Asthma or known history of bronchial hyper-reactivity.
* Chronic renal dysfunction with creatinine clearance \< 45 ml/min.
* Severe comorbidities that in the opinion of the local investigators determine the patient's life expectancy \< 4 years.
* Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05599061
Study Brief:
Protocol Section:
NCT05599061