Ultrasound-guided versus angiography-guided stent placement in people with acute coronary syndrome
Compares two ways of guiding stent placement in people with acute coronary syndrome.
Plain-language title generated from the registry record
Registry title: IVUS-Guided vs Angiography-Guided PCI in Acute Coronary Syndrome
Key facts
- Where
- Seoul, South KoreaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 19 and 90 years old?
Source: NCT07512778, who can take part
Where in South Korea
- The Catholic University of Korea, Eunpyeong St. Mary's HospitalSeoul, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- SUK MIN SEO
- Trial code
- NCT07512778
- Record updated
- 6 April 2026
- Original description
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.Read full original descriptionShow less
Clinical Impact of Intravascular Ultrasound-guided vs. Angiography-guided Coronary Stenting in Patients With Acute Coronary Syndrome: Multicenter, Randomized Control Trial (SAINT-IVUS)
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.
Inclusion: 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; 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: An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs within 6 m after the procedure; Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period; Concern for inability of the patient to comply with study procedures and/or follow-up (e.g., alcohol or drug abuse); 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; At the time of screening, the subject has a malignancy that is not in remission; Non-cardiac co-morbidities with a life expectancy less than 1 year; Compromised left ventricular dysfunction (LVEF <30%); Age >90 years; Cardiogenic shock; Restenotic lesions; Subject belongs to a vulnerable population (per investigator's judgment) or subject unable to read or write; Pregnancy.