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OCT Versus Angiography for Culprit Lesion Revascularization in Acute Myocardial Infarction PatiEnts
Sponsor: Chonnam National University Hospital
Summary
The aim of the study is to compare clinical outcomes between optical coherence tomography-guided versus angiography-guided percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (AMI).
Official title: Randomized Controlled Trial of Optical Coherence Tomography Versus Angiography for Culprit Lesion Revascularization in Patients With Acute Myocardial Infarction
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1500
Start Date
2024-03-25
Completion Date
2029-12-31
Last Updated
2025-09-09
Healthy Volunteers
No
Interventions
Angiography-guided PCI group
The PCI procedure in this group will be performed as standard procedure. After deployment of stent, stent optimization will be done based on angiographic findings. The optimization guided by angiography should meet the criteria of angiographic residual diameter stenosis less than 10% by visual estimation and the absence of flow limiting dissection (≥Type C dissection). When angiographic under-expansion of the stent is suspected, adjunctive balloon dilatation will be strongly recommended.
Optical coherence tomography-guided PCI group
\[Stent Optimization\] 1. Stent Expansion: Visually assess residual angiographic diameter stenosis \<10% "AND" ① In non-LM lesions: In-stent minimal lumen area (MSA) \>80% of the average reference lumen area "OR" \>4.5 mm2 ② In LM lesion: MSA\>7 mm2 for distal LM and \>8 mm2 for proximal LM 2. Stent Apposition: No major malapposition (defined as a distance from stent strut to adjacent intima ≥400 um and \< 1mm length) of the stent over its entire length against the vessel wall 3. Edge Dissection: No major edge dissection in the proximal or distal reference segments, defined as 5 mm from the edge of the stent, extended to media layer with potential to provoke flow disturbances (defined as \>60° of the circumference of the vessel at site of dissection and/or \>2 mm in length of dissection flap)
Locations (21)
Dong-A University College of Medicine
Busan, South Korea
Kosin University Gospel Hospital
Busan, South Korea
Kyungpook National University Hospital
Daegu, South Korea
Yeungnam University Medical Center
Daegu, South Korea
Daegu Catholic University Medical Center
Daegu, South Korea
Chonnam National University
Gwangju, South Korea
Wonkwang University Hospital
Iksan, South Korea
International St. Mary's Hospital
Incheon, South Korea
Jeju National University Hospital
Jeju City, South Korea
Jeonbuk National University Hospital
Jeonju, South Korea
Gyeongsang National University Hospital
Jinju, South Korea
Kyung Hee University Hospital
Seoul, South Korea
Kangbuk Samsung Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Chung-Ang University Hospital
Seoul, South Korea
Ewha Womans University Seoul Hospital
Seoul, South Korea
Ewha Womans University Mokdong Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
St. Carollo Hospital
Suncheon, South Korea
Uijeongbu St Mary's Hospital
Uijeongbu-si, South Korea
Ulsan University Hospital
Ulsan, South Korea