IVUS-guided versus angiography-guided stent placement for 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)

This test will see if using intravascular ultrasound (IVUS) to guide stent placement helps adults with acute coronary syndrome more than standard angiography-guided PCI.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1500 (estimated)
• Ages: 19 Years to 90 Years
• Sex: All
• Sponsor: Eunpyeong St. Mary's Hospital (other)
• Locations: 1 site (Seoul, Eunpyeong-gu)
• Trial ID: NCT07512778 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, randomized controlled trial enrolling 1,500 adults with acute coronary syndromes who will be randomized 1:1 to IVUS-guided PCI or angiography-guided PCI. Operators will use Synergy-platform drug-eluting stents and follow standardized procedural protocols to optimize stent sizing and deployment. Clinical and angiographic follow-up visits will track outcomes including major cardiac events and procedural complications. The trial aims to determine whether the additional vessel imaging from IVUS improves clinical outcomes despite added procedure time and cost.

Who should consider this trial

Good fit: Adults (≥19 years) with unstable angina or acute MI (NSTEMI or STEMI) who have an identifiable culprit lesion with ≥70% stenosis in a 2.5–5.0 mm vessel that is suitable for Synergy stent implantation are ideal candidates.

Not a fit: Patients older than 90 years, those with known hypersensitivity to device materials or metals, those whose lesions are unsuitable for the Synergy stent, or those who do not require stent implantation are unlikely to receive benefit from this approach.

Why it matters

Potential benefit: If successful, IVUS guidance could reduce major cardiac events and improve stent placement quality for patients with acute coronary syndrome.

How similar studies have performed: Prior studies and registries have shown IVUS can improve stent sizing and outcomes in stable coronary disease, but rigorous randomized evidence in acute coronary syndrome populations remains limited.

Eligibility criteria

Inclusion Criteria:

1. Patients 19 years of age or older
2. Patients with unstable angina pectoris, and acute MI including NSTEMI or STEMI.
3. 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
4. All lesions must be suitable for treatment with the Synergy stent system, or other Synergy platform iteration
5. The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

1. Age \>90 years
2. 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.
3. Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to antiplatelet drugs, including both aspirin and P2Y12 inhibitors
4. An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs within 6 m after the procedure.
5. Cardiogenic shock
6. Restenotic lesions
7. Compromised left ventricular dysfunction (LVEF \<30%)
8. At the time of screening, the subject has a malignancy that is not in remission
9. Non-cardiac co-morbidities with a life expectancy less than 1 year
10. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
11. Subject belongs to a vulnerable population (per investigator's judgment) or subject unable to read or write
12. Concern for inability of the patient to comply with study procedures and/or follow-up (e.g., alcohol or drug abuse)
13. Pregnancy

Where this trial is running

Seoul, Eunpyeong-gu

• The Catholic University of Korea, Eunpyeong St. Mary's Hospital — Seoul, Eunpyeong-gu, South Korea (RECRUITING)

Study contacts

• Principal investigator: Suk Min Seo, MD, PhD — The Catholic University of Korea Eunpyeong St. Mary's Hospital
• Study coordinator: SUK MIN SEO, Assisted Professor

Conditions: Acute Coronary Syndromes, Intravascular Ultrasound, IVUS-guided PCI, Angiography-guided PCI