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

ConditionsST Elevation Myocardial Infarction Myocardial Infarction

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age19+

SponsorChonnam National University Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Subject must be at least 19 years of age

Acute ST-segment elevation myocardial infarction (STEMI)

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Angiography-guided PCI group
Procedure/Surgery
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/Surgery
\[Stent Optimization\] 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)

Treatment groups

1,500 Participants

are divided into 2 treatment groups

Group A: Angiography-guided PCIActive comparator 1 intervention

Group B: Optical coherence tomography-guided PCIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Target vessel failure

a composite of cardiac death, target-vessel myocardial infarction, clinically-driven target-vessel repeat revascularization, definite or probable stent thrombosis

Time frame