NCT07512778

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,500 (estimated)
• Sponsor: SUK MIN SEO · Academic / Other
• Sex: All
• Age: 19 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Coronary artery disease is a condition characterized by a high incidence and mortality rate globally. Percutaneous coronary intervention (PCI) stands as a pivotal procedure in the diagnosis and treatment of this disease. Although coronary angiography (CA) is the standard imaging used in coronary stent implantation, it has a limitation in that it only provides two-dimensional images of the coronary arteries. To overcome this limitation, intravascular ultrasound (IVUS) can be utilized, allowing for the visualization of three-dimensional images such as intravascular plaque and morphological characteristics within the vessel, thereby offering more detailed information essential for optimal stent placement. Theoretically, IVUS-guided drug-eluting stent insertion could bring about a reduction in major cardiac events in patients with complex lesions and those at high risk, but most studies have excluded patients with acute coronary syndrome (ACS). The utilization of IVUS demands additional costs and time and might escalate the risk of intravascular complications in certain circumstances. However, the use of IVUS can facilitate a more accurate evaluation of plaque properties and morphology, assisting in determining more effective treatment strategies, and potentially contributing to lowering the risk of major cardiac events in patients suffering from acute myocardial infarction. The objective of this study is to observe and compare the clinical impact between IVUS-guided drug-eluting stent insertion and angiography-guided drug-eluting stent insertion in patients with ACS over a span of 24 months. To this end, the investigators have planned a prospective, multi-institutional, randomized controlled trial, setting the primary outcome measurement as the target vessel failure rate over two years. The study will encompass 1500 patients, who will be assigned randomly at a 1:1 ratio to either the IVUS-guided or angiography-guided groups. The study participants will be recruited from 15 leading domestic PCI centers. This research intends to chart the future course of ACS treatment, aspiring to surmount the current limitations of the technologies being employed. It is anticipated that in patients with ACS, IVUS-guided stent insertion during drug-eluting stent implantation might present superior clinical long-term prognoses compared to simple angiography-guided insertion.

Conditions

• Acute Coronary Syndromes (ACS)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-13
• Primary completion: 2030-12-31
• Completion: 2031-12-31
• First posted: 2026-04-06
• Last updated: 2026-04-06

Locations

1 site across 1 country: South Korea