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

Prior treatment

• 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)

Other illness

• 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

Lab values

• Compromised left ventricular dysfunction (LVEF \<30%)

Age

• Age \>90 years

Other

• Cardiogenic shock
• Restenotic lesions
• Subject belongs to a vulnerable population (per investigator's judgment) or subject unable to read or write
• Pregnancy

• 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.