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 @ 7:04 PM
Ignite Modification Date:
2025-12-24 @ 7:04 PM
NCT ID:
NCT05388357
Eligibility Criteria:
Inclusion Criteria:
* Men or women at least 19 years of age
* Patients with typical symptoms or objective evidence of myocardial ischemia and eligible for coronary angioplasty.
* Subject with severe coronary artery disease undergoing PCI
* Written informed consent
Exclusion Criteria:
* Angiographic exclusion criteria 1) Left main lesion 2) Chronic total occlusion 3)Graft vascular lesion 4) Requiring two-stent techniques for coronary bifurcation lesions 5)Any lesion characteristics resulting in the expected inability to deliver OCT catheter to the lesion ( eg,tortuosity, moderate or severe vessel calcification)
* Acute or chronic renal dysfunction (Plasma creatinine 2.0mg/dL or more) except patients undergoing dialysis
* Primary coronary angioplasty in ST-elevation myocardial infarction(within 12-24 hours of symptom onset)
* Previous PCI with BVS
* LV dysfunction (LVEF) \< 30%
* Hypersensitivity to DES and its components or there is a reason for prohibition (everolimus, cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers)
* Patients who require surgery requiring discontinuation of antiplatelet drugs within 1 year of the procedure
* Life expectancy \< 1 year for any disease
* Pregnancy or breast-feeding
* Patients unsuitable for enrollment judged by the Investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT05388357
Study Brief:
Protocol Section:
NCT05388357