None listed
Conditions
Interventions
Medical Device, Procedure/Surgery : 1. Angiography-guided PCI
The PCI procedure in this group will be performed as standard procedure. After deployment of stent, stent optimization will be done based
Sponsors
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiac death;Target vessel-related myocardial infarction;Clinically-driven target vessel revascularization | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause death;Myocardial infarction; periprocedural MI or spontaneous MI;Any revascularization: target vessel vs. non-target vessel, target lesion vs. non-target lesion, clinically driven vs. non-clinically driven;Stent thrombosis ;Device success (Device level analysis) or procedural success;Total procedural time;Total amount of contrast use;ncidence of contrast-induced nephropathy, defined as an increase in serum creatinine of =0.5mg/dL or =25% from baseline within 48-72 hours after contrast agent exposure | — |
Countries
Korea, Republic of
Contacts
Public ContactSuk Min Seo
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Outcome results
None listed