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

NCT05388357 | Completed DMC

• 1 other identifier: AMCCV2022-02
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 13

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 OCT and Procedural MACE

Conditions

Coronary Vessels; Procedure PCI

Keywords

OCT, AI ,PCI

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (11)

• Procedural success

  24hours

• OCT endpoint

  24hours

• Angiographic endpoint

  24hours

• Death

  6month

• MI

  6month

Study Arms (2)

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.

Other: Intervention Procedure: PCI

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.

Other: Intervention Procedure: PCI

Interventions

Intervention Procedure: PCI OTHER

Percutaneous Coronary Intervention

AI -guided PCI; OCT-guided PCI

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead
• Korea Medical Device Development Fund: collaborator
• Medipixel,Inc: collaborator

Study Sites (13)

Sejong General Hospital

Bucheon-si, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Kyungpook National University Hospital

Daegu, South Korea

Location

GangNeung Asan Hospital

Gangneung, South Korea

Location

Seoul National University Bundang hospital

Gyeonggi-do, South Korea

Location

Soon Chun Hyang University Hospital Bucheon

Gyeonggi-do, South Korea

Location

Yougin Severance Hospital

Gyeonggi-do, South Korea

Location

Chungbuk National University Hospital

Jungbuk, South Korea

Location

Pusan National University Hospital

Pusan, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Hanyang University Medical Center

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

Related Publications (2)

• 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.

  PMID: 39614852 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.

  PMID: 38723880 DERIVED

MeSH Terms

Conditions

Ornithine Carbamoyltransferase Deficiency Disease

Condition Hierarchy (Ancestors)

Urea Cycle Disorders, Inborn; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jung- min Ahn

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 24, 2022
• Study Start: October 4, 2022
• Primary Completion: June 30, 2024
• Study Completion: October 2, 2024
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (13)