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

Study Overview
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Brief Summary
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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

Official Title
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A Prospective, Open Label, Multi-center, Dual Arm, Randomized, Trial : AI-QCA Guided PCI Versus Optical Coherence Tomography Guided PCI

Conditions
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Coronary Vessels, Procedure PCI

Intervention / Treatment
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* Other: Intervention Procedure: PCI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AI -guided PCI<br>based on AI-QCA measurement, a drug eluting stent of an appropriate size is inserted and then high-pressure balloon dilatation is additionally actively performed in all patients. | Other: Intervention Procedure: PCI<br>* Percutaneous Coronary Intervention<br>|
| Active Comparator: OCT-guided PCI<br>In the OCT group, the size of the stent is determined using intravascular optical coherence tomography, and balloon dilatation is additionally performed if necessary. | Other: Intervention Procedure: PCI<br>* Percutaneous Coronary Intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Stent Area by Final OCT | Minimal Stent Area evaluated by OCT after stenting of the target lesion | 1hour | 
| Procedural MACE | Procedural MACE was defined as procedural complication ( angio graphic dissection , perforation, thrombus, or acute closure requiring active intervention | 24hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success | stent expansion is 90% or more by OCT and no failure of the target lesion occurred within 24 hours after the procedure. | 24hours | 
| OCT endpoint | stent expansion,stent malaposition,tissue or thrombus protrusion,untreated reference segment disease | 24hours | 
| Angiographic endpoint | stent minimum diameter (minimal lumen diameter),stenosis (percent diameter stenosis)acute luminal gain,maximum stent or reference vessel diameter,aortic dissection | 24hours | 
| Death | cardiac, vascular, non-cardiovascular death | 1year | 
| MI | periprocedural/spontaneous MI | 1year | 
| Stent thrombosis | definite/probable | 1year | 
| Revascularization | Revascularization | 1year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCT, AI ,PCI