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

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.

Eligibility

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

Conditions2

Browse More Trials