OCT Versus Angiography for Culprit Lesion Revascularization in Acute Myocardial Infarction PatiEnts

Sponsor
Chonnam National University Hospital
Study ID
NCT06227754
Status
Recruiting
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Conditions

  • Myocardial Infarction
  • ST Elevation Myocardial Infarction

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Angiography-guided PCI group — PROCEDURE
    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 — PROCEDURE
    \[Stent Optimization\] 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)

Study Details

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).

Key Dates

First listed
Jan 29, 2024
Start date
Mar 25, 2024
Status verified
May 2026
Primary completion
Mar 31, 2031
Completion
Dec 31, 2031

Study Design

Enrollment
1,500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Angiography-guided PCI
    The PCI procedure in this group will be performed as standard procedure.
  • Experimental: Optical coherence tomography-guided PCI
    Use of OCT will be allowed at any step of PCI (pre-PCI, during PCI and post-PCI), but OCT after stent implantation will be mandatory. In this group, the recommendations for selecting reference segment, selecting appropriate size of stent, and stent optimization are as follows. OPTIS imaging catheter (Abbott Vascular) will be used for the imaging arm according to MLD MAX algorithm.

Primary Outcome Measure

Target vessel failure [ Time Frame: 2 years after last patient enrollment ]

Central Contacts

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