OCT Versus Angiography for Culprit Lesion Revascularization in Acute Myocardial Infarction PatiEnts
NCT06227754 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1500
Last updated 2026-05-08
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).
Conditions
- ST Elevation Myocardial Infarction
- Myocardial Infarction
Interventions
- PROCEDURE
-
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.
- PROCEDURE
-
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)
Sponsors & Collaborators
-
Samsung Medical Center
collaborator OTHER -
Chonnam National University Hospital
lead OTHER
Principal Investigators
-
Young Joon Hong, MD, PhD · Chonnam National University
-
Joo-Yong Hahn, MD, PhD · Samsung Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-03-25
- Primary Completion
- 2031-03-31
- Completion
- 2031-12-31
Countries
- South Korea
Study Locations
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