Coronary Artery Disease
Conditions
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.
Interventions
DEVICEPCI
Coronary Intervention
Sponsors
Iwate Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 84 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with new coronary lesion indicated for PCI using DES 2. Patients whose age at acquisition of consent is 20 to less than 85 years 3. Patients who themselves or whose representatives showed the written consent 4. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-weeks strut coverage rate by FD-OCT | 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. |
Countries
Japan
Outcome results
None listed