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RECRUITING
NCT07512778
NA

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

Sponsor: SUK MIN SEO

View on ClinicalTrials.gov

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.

Official title: Clinical Impact of Intravascular Ultrasound-guided vs. Angiography-guided Coronary Stenting in Patients With Acute Coronary Syndrome: Multicenter, Randomized Control Trial (SAINT-IVUS)

Key Details

Gender

All

Age Range

19 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

1500

Start Date

2025-03-13

Completion Date

2031-12-31

Last Updated

2026-04-06

Healthy Volunteers

No

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.

Locations (1)

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

Seoul, Eunpyeong-gu, South Korea