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 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT06368635
Eligibility Criteria:
Inclusion Criteria:
* Informed Consent available.
* Age 45-80 years.
* Stable coronary lesions.
* target vessel with intermediate coronary lesion (40-80% diameter stenosis and FFR ≥0.8； or severe stenosis（\>80%）after successful PCI and FFR ≥0.8
Exclusion Criteria:
* Previous myocardial infarction in the territory of distribution of the target vessel.
* Aortic valve stenosis (moderate or severe) .
* Severe left ventricle hypertrophy.
* Left ventricle moderate systolic dysfunction (EF \< 35%).
* Contraindications to adenosine.
* Previous CABG (Coronary artery bypass grafting) with permeable grafts.
* Contraindication to stent implantation.
* Severe anemia.
* Unilateral or bilateral carotid artery stenosis (\> 50%).
* Unilateral or bilateral middle cerebral arteries (\>50%).
* Previous cognitive decline, baseline MoCA less than 16 points.
* Coagulopathies or chronic anticoagulation.
* Platelets \< 75000 o \> 700.000.
* Previous stroke or intracranial hemorrhage.
* Contraindication to MRI.
* Chronic Renal Failure contraindicating gadolinium infusion during MRI: estimated glomerular filtration rate (eGFR) \< 60 ml/min), hemodialysis, previous renal transplantation.
* Pacemaker/ Implantable Cardioverter Device with contraindication to MRI.
* Planned cardiac surgery.
* Life expectancy \< 1 years.
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
80 Years
Study:
NCT06368635
Study Brief:
Protocol Section:
NCT06368635