AI Quantitative Coronary Angiography Versus Optical Coherent Tomography Guidance for Coronary Stent Implantation
NCT ID: NCT05388357
Last Updated: 2024-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
400 participants
INTERVENTIONAL
2022-10-04
2024-10-02
Brief Summary
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Detailed Description
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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 appropriate stent size for implantation. The procedure is performed as follows:
1. Select the optimal projection angle providing the best view of the lesion.
2. Provide sufficient nitroglycerin for vasodilation. If the lesion is severely stenotic, perform balloon angioplasty, followed by nitroglycerin supply.
3. Perform AI-QCA to measure the length of the lesion and the inside diameter of the proximal and distal reference vessels.
4. Determine the stent length and size according to the AI-QCA measurements. Select a stent that is 20% larger than the distal reference vessel diameter and that can provide coverage for both the proximal and distal reference vessels.
5. Perform high-pressure balloon dilation after stent implantation, with the final balloon size being 20% larger than the distal and proximal reference vessel diameters.
6. Perform a final coronary angiogram if no procedural complications are observed on the angiogram and stent expansion is confirmed.
7. Perform a final OCT to measure the stent area (mm2), the primary efficacy endpoint.
8. If significant suboptimal stent results, such as severe underexpansion, extensive strut malapposition, or major stent edge dissection, occur, additional procedures to correct them are permitted to ensure patient safety, although they are generally discouraged. (The primary endpoint will be assessed by OCT run before such correction.)
2. OCT guided DES implantation
After coronary angiography, OCT is performed to determine the appropriate stent size for implantation. After the stent procedure, OCT is performed again to check for an area that is smaller than the area of distal reference vessel and for sufficient dilatation. If necessary, high-pressure balloon dilation is performed to minimize residual stenosis. The procedure is performed as follows:
1. Select the optimal projection angle providing the best view of the lesion.
2. Provide sufficient nitroglycerin for vasodilation. If the lesion is severely stenotic, perform balloon angioplasty, followed by nitroglycerin supply.
3. Perform OCT to obtain pre-procedural images of the vessel. If there is a stenosis and OCT images cannot be obtained, perform OCT after adequate balloon angioplasty.
4. Determine the length and size of the stent to be implanted according to the OCT images. Select the stent size in consideration of the mean lumen diameter and mean external elastic lamina (EEL) diameter of the distal reference vessel. If the EEL is not observed, use a stent that is 0.25 mm larger than the mean lumen diameter. Select the length by measuring the length of the proximal and distal reference vessel segments on the OCT.
5. Perform high-pressure balloon dilation after stent implantation. Select the final balloon size by considering the inside diameters of the distal and proximal reference vessels and EEL diameter.
6. Perform OCT. If no procedure-related complications are observed and there is no underexpansion or malapposition of the stent, perform a final coronary angiogram. If procedure-related complications or underexpansion or malapposition of the stent is observed, correct it, and then perform a final OCT to measure the stent area (mm2), the primary efficacy endpoint.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AI -guided PCI
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.
Intervention Procedure: PCI
Percutaneous Coronary Intervention
OCT-guided PCI
In the OCT group, the size of the stent is determined using intravascular optical coherence tomography, and balloon dilatation is additionally performed if necessary.
Intervention Procedure: PCI
Percutaneous Coronary Intervention
Interventions
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Intervention Procedure: PCI
Percutaneous Coronary Intervention
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
ALL
No
Sponsors
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Korea Medical Device Development Fund
UNKNOWN
Medipixel,Inc
UNKNOWN
Asan Medical Center
OTHER
Responsible Party
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Jung-min Ahn
Professor
Principal Investigators
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Jung- min Ahn
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Sejong General Hospital
Bucheon-si, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
GangNeung Asan Hospital
Gangneung, , South Korea
Seoul National University Bundang hospital
Gyeonggi-do, , South Korea
Soon Chun Hyang University Hospital Bucheon
Gyeonggi-do, , South Korea
Yougin Severance Hospital
Gyeonggi-do, , South Korea
Chungbuk National University Hospital
Jungbuk, , South Korea
Pusan National University Hospital
Pusan, , South Korea
Asan Medical Center
Seoul, , South Korea
Hanyang University Medical Center
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Countries
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References
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Kim Y, Yoon HJ, Suh J, Kang SH, Lim YH, Jang DH, Park JH, Shin ES, Bae JW, Lee JH, Oh JH, Kang DY, Kweon J, Jo MW, Yun SC, Park DW, Kim YH, Park SJ, Park H, Ahn JM; FLASH Trial Investigators. Artificial Intelligence-Based Fully Automated Quantitative Coronary Angiography vs Optical Coherence Tomography-Guided PCI: The FLASH Trial. JACC Cardiovasc Interv. 2025 Jan 27;18(2):187-197. doi: 10.1016/j.jcin.2024.10.025. Epub 2024 Oct 30.
Kim Y, Park H, Yoon HJ, Suh J, Kang SH, Lim YH, Jang DH, Park JH, Shin ES, Bae JW, Lee JH, Oh JH, Kang DY, Kweon J, Jo MW, Park DW, Kim YH, Ahn JM; FLASH Trial Investigators. Fully automated quantitative coronary angiography versus optical coherence tomography guidance for coronary stent implantation (FLASH): Study protocol for a randomized controlled noninferiority trial. Am Heart J. 2024 Sep;275:86-95. doi: 10.1016/j.ahj.2024.05.004. Epub 2024 May 7.
Other Identifiers
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AMCCV2022-02
Identifier Type: -
Identifier Source: org_study_id
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