Comparison of MECHANISM of Early and Late Vascular Responses Following Treatment of ST-elevation Acute Myocardial Infarction With Two Different Everolimus-eluting Stents: Randomized Controlled Trial Between Biodegradable Polymer and Durable Polymer Stent
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Iwate Medical University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- 2-weeks strut coverage rate by FD-OCT
- Last Updated
- 5 years ago
Overview
Brief Summary
To place two different everolimus-eluting stents (EES), a bioabsorbable polymer EES (Synergy®) and a permanent-type polymer EES (Xience®), randomly to the ST-elevation acute myocardial infarction (AMI) and to observe and compare the early and chronic vascular responses using the frequency domain optical coherence tomography (FD-OCT). The primary endpoint is the 2-week strut coverage rate by FD-OCT.
Investigators
Yoshihiro Morino
Professor
Iwate Medical University
Eligibility Criteria
Inclusion Criteria
- •Patients with new coronary lesion indicated for PCI using DES
- •Patients whose age at acquisition of consent is 20 to less than 85 years
- •Patients who themselves or whose representatives showed the written consent
- •Patients who will undergo cardiac catheterization 2 weeks later (staged PCI on the other vessel or confirmatory angiography at the treated site)
Exclusion Criteria
- •If the following exclusion criteria are satisfied, the patient should not be enrolled in this study even after acquisition of patient's consent:
- •When the follow-up after 12 months is considered difficult (the patient's residence should also be considered)
- •When there is no obvious ACS finding in angiography (decisions should be left to operator)
- •Patients with shock
- •Patients whose culprit lesion is the left main coronary trunk
- •Lesion with the reference vascular diameter of \<2.0 mm or ≥4.5 mm visually
- •AMI that occurred newly at the site where a stent has already been placed
- •Chronic renal failure in which the serum creatinine concentration at visit is ≥2.0 mg/dL
- •Patients undergoing hemodialysis
- •Tumor-bearing patients whose life prognosis is expected to be within 2 years
Outcomes
Primary Outcomes
2-weeks strut coverage rate by FD-OCT
Time Frame: 2-weeks
In this clinical study, the 2-week covered strut rate by FD-OCT should be considered the primary endpoint, and the non-inferiority of Synergy® to the present standard treatment, Xience®, established in the control group in the treatment of STEMI, should be demonstrated.