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Fully automated quantitative coronary angiography versus optical coherence tomography guidance for coronary stent implantation (FLASH): Study protocol for a randomized controlled noninferiority trial.
Kim, Yongcheol; Park, Hanbit; Yoon, Hyuck-Jun; Suh, Jon; Kang, Si-Hyuck; Lim, Young-Hyo; Jang, Duck Hyun; Park, Jae Hyoung; Shin, Eun-Seok; Bae, Jang-Whan; Lee, Jang Hoon; Oh, Jun-Hyok; Kang, Do-Yoon; Kweon, Jihoon; Jo, Min-Woo; Park, Duk-Woo; Kim, Young-Hak; Ahn, Jung-Min.
Afiliación
  • Kim Y; Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine and Cardiovascular Center, Yongin Severance Hospital, Yongin, Korea.
  • Park H; Department of Medicine, Division of Cardiology, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, Korea.
  • Yoon HJ; Department of Internal Medicine and Cardiovascular Research Institute, Keimyung University Dongsan Hospital, Daegu, Korea.
  • Suh J; Department of Cardiology, Soon Chun Hyang University Hospital Bucheon, Bucheon, Korea.
  • Kang SH; Department of Internal Medicine, Cardiovascular Center, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
  • Lim YH; Department of Internal Medicine, Division of Cardiology, Hanyang University College of Medicine, Seoul, Korea.
  • Jang DH; Department of Internal Medicine, Division of Cardiology, Sejong General Hospital, Bucheon, Korea.
  • Park JH; Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.
  • Shin ES; Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.
  • Bae JW; Department of Internal Medicine, Division of Cardiology, Chungbuk National University College of Medicine, Cheongju, Korea.
  • Lee JH; Department of Internal Medicine, Kyungpook National University Hospital, School of Medicine, Kyungpook National University, Daegu, Korea.
  • Oh JH; Department of Cardiology and Medical Research Institute, Pusan, Pusan National University, National University Hospital, Busan, Korea.
  • Kang DY; Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
  • Kweon J; Department of Biomedical Engineering, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
  • Jo MW; Department of Preventive Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
  • Park DW; Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
  • Kim YH; Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
  • Ahn JM; Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Am Heart J ; 275: 86-95, 2024 Sep.
Article en En | MEDLINE | ID: mdl-38723880
ABSTRACT

BACKGROUND:

Artificial intelligence-based quantitative coronary angiography (AI-QCA) has been developed to provide a more objective and reproducible data about the severity of coronary artery stenosis and the dimensions of the vessel for intervention in real-time, overcoming the limitations of significant inter- and intraobserver variability, and time-consuming nature of on-site QCA, without requiring extra time and effort. Compared with the subjective nature of visually estimated conventional CAG guidance, AI-QCA guidance provides a more practical and standardized angiography-based approach. Although the advantage of intravascular imaging-guided PCI is increasingly recognized, their broader adoption is limited by clinical and economic barriers in many catheterization laboratories.

METHODS:

The FLASH (fully automated quantitative coronary angiography versus optical coherence tomography guidance for coronary stent implantation) trial is a randomized, investigator-initiated, multicenter, open-label, noninferiority trial comparing the AI-QCA-assisted PCI strategy with optical coherence tomography-guided PCI strategy in patients with significant coronary artery disease. All operators will utilize a novel, standardized AI-QCA software and PCI protocol in the AI-QCA-assisted group. A total of 400 patients will be randomized to either group at a 11 ratio. The primary endpoint is the minimal stent area (mm2), determined by the final OCT run after completion of PCI. Clinical follow-up and cost-effectiveness evaluations are planned at 1 month and 6 months for all patients enrolled in the study.

RESULTS:

Enrollment of a total of 400 patients from the 13 participating centers in South Korea will be completed in February 2024. Follow-up of the last enrolled patients will be completed in August 2024, and primary results will be available by late 2024.

CONCLUSION:

The FLASH is the first clinical trial to evaluate the feasibility of AI-QCA-assisted PCI, and will provide the clinical evidence on AI-QCA assistance in the field of coronary intervention. CLINICAL TRIAL REGISTRATION URL https//www. CLINICALTRIALS gov. Unique identifier NCT05388357.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Enfermedad de la Arteria Coronaria / Stents / Angiografía Coronaria / Tomografía de Coherencia Óptica / Intervención Coronaria Percutánea Límite: Female / Humans / Male Idioma: En Revista: Am Heart J Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Enfermedad de la Arteria Coronaria / Stents / Angiografía Coronaria / Tomografía de Coherencia Óptica / Intervención Coronaria Percutánea Límite: Female / Humans / Male Idioma: En Revista: Am Heart J Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos