OCT Versus Angiography for Culprit Lesion Revascularization in Acute Myocardial Infarction PatiEnts
Randomized Controlled Trial of Optical Coherence Tomography Versus Angiography for Culprit Lesion Revascularization in Patients With Acute Myocardial Infarction
Chonnam National University Hospital
1,500 participants
Mar 25, 2024
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria5
- Subject must be at least 19 years of age
- Acute ST-segment elevation myocardial infarction (STEMI)
- *STEMI: ST-segment elevation ≥0.1 mV in ≥2 contiguous leads or documented newly developed left bundle-branch block1
- Primary percutaneous coronary intervention (PCI) in < 12 h after the onset of symptoms for STEMI patients
- Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and PCI and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
Exclusion Criteria9
- Target lesions not amenable for PCI by operators' decision
- Ostial lesions located in left main vessel or right coronary artery (left main body or distal bifurcation lesions can be enrolled by operator's discretion)
- Creatinine clearance ≤30 ml/min/1.73 m2 and not on dialysis (chronic dialysis dependent patients are eligible for enrolment regardless of creatinine clearance)
- Cardiogenic shock (Killip class IV) at presentation
- Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, or Everolimus
- Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
- Pregnancy or breast feeding
- Non-cardiac co-morbid conditions are present with life expectancy <2 year or that may result in protocol non-compliance (per site investigator's medical judgment)
- Unwillingness or inability to comply with the procedures described in this protocol
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
\[Stent Optimization\] 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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06227754