Actively Recruiting

Phase Not Applicable
Age: 19Years - 90Years
All Genders
NCT07512778

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

Led by SUK MIN SEO · Updated on 2026-04-06

1500

Participants Needed

1

Research Sites

354 weeks

Total Duration

On this page

Sponsors

S

SUK MIN SEO

Lead Sponsor

B

Boston Scientific Korea Co. Ltd

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 19Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 19 years of age or older
  • Diagnosis of unstable angina pectoris or acute myocardial infarction including NSTEMI or STEMI
  • Coronary artery disease with greater than 70% stenosis and an identifiable culprit lesion suitable for stent implantation
  • Lesions suitable for treatment with the Synergy stent system or its platform iterations
  • Patient or guardian agrees to study protocol, clinical and angiographic follow-up, and provides informed written consent
Not Eligible

You will not qualify if you...

  • Age over 90 years
  • Known hypersensitivity or contraindication to device materials (everolimus, polymers) or metals (cobalt, chromium, nickel, platinum, tungsten, acrylic, fluoro polymers) that cannot be premedicated
  • Absolute contraindications or allergies to iodinated contrast or antiplatelet drugs including aspirin and P2Y12 inhibitors
  • Planned elective surgery requiring interruption of antiplatelet drugs within 6 months after PCI
  • Cardiogenic shock
  • Restenotic lesions
  • Left ventricular dysfunction with ejection fraction below 30%
  • Active malignancy not in remission
  • Non-cardiac illnesses with life expectancy less than 1 year
  • Current participation in another investigational drug or device study without completed primary endpoint follow-up
  • Vulnerable populations or inability to read/write
  • Concern about patient’s ability to comply with study procedures or follow-up (e.g., alcohol or drug abuse)
  • Pregnancy

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

Seoul, Eunpyeong-gu, South Korea, 03312

Actively Recruiting

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Research Team

S

SUK MIN SEO, Assisted Professor

CONTACT

Y

YUN JU KANG, RN,CRC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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