AI Quantitative Coronary Angiography Versus Optical Coherent Tomography Guidance for Coronary Stent Implantatio

Not Applicable

Recruiting

Conditions: Diseases of the circulatory system

Registration Number: KCT0007464

Lead Sponsor: Asan Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 400

Inclusion Criteria

Inclusion Criteria:
1. Men or women at least 19 years of age
2. Patients with typical symptoms or objective evidence of myocardial ischemia and eligible for coronary angioplasty.
3. Subject with severe coronary artery disease undergoing PCI
4. Written informed consent

Exclusion Criteria

1. Angiographic exclusion criteria
1) Left main lesion
2) Chronic total occlusion
3) Graft vascular lesion
4) Bifurcation lesion required Two stenting
5) Any lesion characteristics resulting in the expected inability to deliver the OCT catheter to the lesion ( eg,tortuosity, moderate or severe vessel calcification)
2. Acute or chronic renal dysfunction (Plasma creatinine 2.0mg/dL or more)
3. Primary coronary angioplasty in ST-elevation myocardial infarction(within 12-24 hours of symptom onset)
4. Previous PCI with BVS
5. LV dysfunction (LVEF) < 30%
6. Hypersensitivity to DES and its components or there is a reason for prohibition
(everolimus, cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers)
7. Patients requiring surgery to discontinue antiplatelet drugs within one year of treatment
8. Life expectancy < 1 year for any disease
9. Pregnancy or breast-feeding
10. Patients unsuitable for enrollment judged by the Investigator

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Endpoint: Minimal Stent Area(mm2) By Final OCT;Primary Safety Endpoint: Procedural MACE (Procedural MACE was defined as procedural complications(angiographic dissection, perforation, thrombus or acute closure) requiring active intervention

Secondary Outcome Measures

Name	Time	Method
Procedural success : stent expansion is 90% or more by OCT and no failure of the target lesion occurred within 24 hours after the procedure.;OCT endpoint : stent expansion, stent malaposition, tissue or thrombus protrusion, untreated reference segment disease;Angiographic endpoin : stent minimum diameter (minimal lumen diameter), stenosis (percent diameter stenosis), acute luminal gain, maximum stent or reference vessel diameter, aortic dissection;Death : cardiac, vascular, non-cardiovascular death;MI : periprocedural/spontaneous MI;Stent thrombosis;Revascularization