Status:
COMPLETED
AI Quantitative Coronary Angiography Versus Optical Coherent Tomography Guidance for Coronary Stent Implantation
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Korea Medical Device Development Fund
Medipixel,Inc
Conditions:
Coronary Vessels
Procedure PCI
Eligibility:
All Genders
19+ years
Phase:
NA
Brief 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...
Detailed Description
1. AI-QCA-assisted DES implantation After coronary angiography, AI-QCA software will be used to determine the lesion length and the reference vessel diameter in real time to determine the appropri...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 2 2024
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT05388357
Start Date
October 4 2022
End Date
October 2 2024
Last Update
October 24 2024
Active Locations (13)
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1
Sejong General Hospital
Bucheon-si, South Korea
2
Keimyung University Dongsan Medical Center
Daegu, South Korea
3
Kyungpook National University Hospital
Daegu, South Korea
4
GangNeung Asan Hospital
Gangneung, South Korea