IVUS-Guided vs Angiography-Guided PCI in Acute Coronary Syndrome
ConditionAcute Coronary Syndromes (ACS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-90
SponsorSUK MIN SEO
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Age >90 years
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
An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs within 6 m after the procedure.
Trial design
Treatments tested in this trial
- IVUS-guided PCI
- Angiography-guided PCI
Treatment groups
1,500 Participants
are divided into 2 treatment groupsSponsors and collaborators
SUK MIN SEO
Lead sponsor
Eunpyeong St. Mary's Hospital
Sponsor institution
Boston Scientific Korea Co. Ltd
Collaborator
Source ClinicalTrials.gov