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| Name | Class |
|---|---|
| Korea Medical Device Development Fund | UNKNOWN |
| Medipixel,Inc | UNKNOWN |
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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
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 appropriate stent size for implantation. The procedure is performed as follows:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI -guided PCI | Experimental | 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. |
|
| OCT-guided PCI | Active Comparator | In the OCT group, the size of the stent is determined using intravascular optical coherence tomography, and balloon dilatation is additionally performed if necessary. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention Procedure: PCI | Other | Percutaneous Coronary Intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Minimal Stent Area evaluated by OCT | Minimal Stent Area evaluated by OCT after stenting of the target lesion | 1hour |
| Procedural complications | Procedural complications including angiographic dissection, perforation, or acute closure requiring active intervention after stent implantation | 24hours |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success | Stent expansion (≥ 90%) in final OCT assessment and successful stent delivery without target-lesion failure in 24 hours | 24hours |
| OCT endpoint | Stent expansion, stent malapposition, intra-stent tissue (plaque or thrombus) protrusion, untreated reference segment disease |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jung- min Ahn | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sejong General Hospital | Bucheon-si | South Korea | ||||
| Keimyung University Dongsan Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39614852 | Derived | 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. | |
| 38723880 |
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| 24hours |
| Angiographic endpoint | Minimal lumen diameter at the stented segment, diameter stenosis at the stented segment, acute gain at the stented segment | 24hours |
| Death | All-cause death , Cardiac and non-Cardiac death | 6month |
| MI | Any MI( periprocedural/spontaneous MI), Target vessel-MI and non-target vessel-MI | 6month |
| Stent thrombosis | definite/probable | 6month |
| Revascularization | Any revascularization,Target vessel and target lesion revascularization | 6month |
| Composite of event | Composite of all-cause death, myocardial infarction, stent thrombosis, or revascularization | 6month |
| Quality of life score assessed by the EQ-5D | The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. EQ-5D: the minimum and maximum values are 5 and 25 respectively. EQ VAS: the minimum and maximum values are 0 and 100 respectively. | 6month |
| Quality of life score assessed by Health-related Quality of Life Instrument with 8 Items (HINT-8) | HINT-8 was developed based on 4 health dimensions: physical, mental, social, and positive health dimensions. It consists of climbing stairs, endurance to pain, vitality, working, depression, memory, sleep, and happiness. | 6month |
| Cost-effective analysis | Cost-effective analysis based on average treatment costs for two treatment | 6month |
| 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 |
| 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 |
| Chungbuk National University Hospital | Taebuk | South Korea |
| Ulsan University Hospital | Ulsan | South Korea |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D020163 | Ornithine Carbamoyltransferase Deficiency Disease |
| ID | Term |
|---|---|
| D056806 | Urea Cycle Disorders, Inborn |
| D020739 | Brain Diseases, Metabolic, Inborn |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000592 | Amino Acid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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