IVUS-guided versus angiography-guided stent placement for acute coronary syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: ssm530@catholic.ac.kr
• Phone: 82+010-9090-8491

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.