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 @ 4:55 AM
Ignite Modification Date:
2025-12-25 @ 4:55 AM
NCT ID:
NCT03174418
Eligibility Criteria:
Inclusion Criteria
* Patients with stable or unstable coronary artery disease;
* TIMI 3 on both MV and SB;
* MV visual diameter \> 2.5 mm;
* SB visual diameter \> 2.0 mm;
* Documentation of angiographically-critical (visually estimated percentage diameter stenosis ≥80% \<100%) coronary lesion treated by PCI and underwent post-PCI OCT assessment or angiographically-intermediate (visually estimated percentage diameter stenosis ranging between 30-80%) lesion in the MV considered suitable for conservative management (myocardial revascularization not planned).
Exclusion Criteria
* Age \< 18 years or impossibility to give informed consent.
* Female sex with child-bearing potential.
* Life expectancy of less than 12 months or factors making clinical follow-up difficult (no fixed address, etc.).
* Ascertained or suspected contraindications to prolonged (up to 6 month) double antiplatelet therapy.
* Known hypersensitivity to aspirin, heparin, contrast dye, sirolimus, everolimus, zotarolimus, cobalt, chromium, nickel, tungsten acrylic, and fluoro-polymers.
* Poor cardiac function as defined by left ventricular global ejection fraction ≤ 30%.
* Recent (\< 48 hours) ST-segment elevation myocardial infarction.
* Severe myocardial hypertrophy (interventricular septum thickness \> 15 mm, ECG Sokolow's criteria fulfilled).
* Severe valvular heart disease.
* Significant platelet count alteration (\<100,000 cells/mm3 or \> 700,000 cells/mm3).
* Gastrointestinal bleeding requiring surgery or blood transfusions within 4 previous weeks.
* History of clotting pathology.
* Advance renal failure with glomerular filtration rate \< 30 ml/min (Cockcroft-Gault equation)
* Left main lesion.
* Target bifurcation located on a distal coronary segment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03174418
Study Brief:
Protocol Section:
NCT03174418