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IVUS-Guided vs Angiography-Guided PCI in Acute Coronary Syndrome

NCT07512778 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2026-04-06

No results posted yet for this study

Summary

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.

Conditions

  • Acute Coronary Syndromes (ACS)

Interventions

PROCEDURE

IVUS-guided PCI

Patients 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.

PROCEDURE

Angiography-guided PCI

Patients 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.

Sponsors & Collaborators

  • Boston Scientific Korea Co. Ltd

    collaborator INDUSTRY

  • SUK MIN SEO

    lead OTHER

Principal Investigators

  • Suk Min Seo, MD, PhD · The Catholic University of Korea Eunpyeong St. Mary's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-13
Primary Completion
2030-12-31
Completion
2031-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07512778 on ClinicalTrials.gov