IVUS-Guided vs Angiography-Guided PCI in Acute Coronary Syndrome
ConditionAcute Coronary Syndromes (ACS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-90
SponsorSUK MIN SEO
About this trial
Coronary artery disease is associated with substantial morbidity and mortality worldwide. Percutaneous coronary intervention (PCI) is a pivotal procedure for the treatment of coronary artery disease. Although coronary angiography (CA) is the standard imaging modality used for coronary stent implantation, it provides only two-dimensional images of the coronary arteries. Intravascular ultrasound (IVUS) can provide additional information on plaque characteristics and vessel morphology, which may facilitate optimal stent sizing and procedural optimization. However, IVUS requires additional time and cost and may increase procedural complexity. Evidence regarding the clinical benefit of IVUS-guided PCI in patients with acute coronary syndrome (ACS) remains limited.
This study is a prospective, multicenter, randomized controlled trial designed to compare IVUS-guided PCI versus angiography-guided PCI in patients with ACS. A total of 1,500 participants will be randomized 1:1 to either the IVUS-guided group or the angiography-guided group. Participants will be recruited from 15 PCI centers in Korea. The primary outcome is target vessel failure at 2 years.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients 19 years of age or older
Patients with unstable angina pectoris, and acute MI including NSTEMI or STEMI.
Coronary artery disease defined as >70% stenosis (reference vessel diameter 2.5 - 5.0 mm based on operator assessment) with identifiable culprit lesion indicated stent implantation
All lesions must be suitable for treatment with the Synergy stent system, or other Synergy platform iteration
Disqualifiers
Age >90 years
Subject has known hypersensitivity or contraindication to device material and its degradants (everolimus, poly(L-lactide), poly(DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic, and fluoro polymers that cannot be adequately premedicated.
Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to antiplatelet drugs, including both aspirin and P2Y12 inhibitors
An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs within 6 m after the procedure.
Trial design
Design model
Parallel
Treatments tested in this trial
IVUS-guided PCI
Procedure/SurgeryPatients randomized to the IVUS-guided PCI arm will undergo percutaneous coronary intervention with intravascular ultrasound guidance. IVUS may be used before, during, and after PCI, and post-stent IVUS assessment will be mandatory. IVUS will be used to determine reference vessel dimensions, guide stent sizing and length selection, and optimize stent expansion and apposition according to predefined criteria. Optimization criteria include adequate stent expansion (minimal lumen area ≥90% of the average reference lumen area), absence of major malapposition, absence of major edge dissection, and absence of significant residual stenosis near the stent edges. If these criteria are not met, additional balloon dilation or stent implantation may be performed at the operator's discretion.
Angiography-guided PCI
Procedure/SurgeryPatients randomized to the angiography-guided PCI arm will undergo percutaneous coronary intervention guided by conventional coronary angiography. Stent sizing, length selection, and procedural optimization will be performed according to standard angiographic assessment at the operator's discretion. Routine use of intravascular ultrasound will not be routinely performed in this group. However, IVUS may be used only in bailout situations if deemed necessary by the operator.
Treatment groups
1,500 Participants
are divided into 2 treatment groupsGroup A: IVUS-guided PCIExperimental treatment 1 intervention
Group B: Angiography-guided PCIActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Target Vessel Failure (TVF)
Composite of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization.
Time frame
2 years after randomizationSecondary outcomes
1
Cardiac death
Death resulting from immediate cardiac causes including myocardial infarction, heart failure, arrhythmia, or other cardiac conditions
Time frame
2 years after randomization2
Target vessel-related myocardial infarction
Myocardial infarction attributable to the target vessel treated during the index PCI according to the Fourth Universal Definition of Myocardial Infarction.
Time frame
2 years after randomization3
Clinically driven target vessel revascularization
Repeat percutaneous coronary intervention or coronary artery bypass grafting of the target vessel due to symptoms or objective evidence of myocardial ischemia.
Time frame
2 years after randomization4
All-cause death
Death from any cause.
Time frame
2 years after randomizationSponsors and contacts
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SUK MIN SEO
Lead sponsor
Eunpyeong St. Mary's Hospital
Sponsor institution
Boston Scientific Korea Co. Ltd
Collaborator
Source ClinicalTrials.gov