AI Quantitative Coronary Angiography Versus Optical Coherent Tomography Guidance for Coronary Ste⦠(NCT05388357) | Clinical Trial Compass
CompletedNot Applicable
AI Quantitative Coronary Angiography Versus Optical Coherent Tomography Guidance for Coronary Stent Implantation
South Korea400 participantsStarted 2022-10-04
Plain-language summary
This study is to establish the primary hypothesis thatAI -QCA guided PCI is non-inferior to Optical coherence tomography-guided Percutaneous coronary intervention regarding minimal Stent area by Final OCT and Procedural MACE
Who can participate
Age range19 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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