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 (MECHANISM-AMI-RCT)

NCT ID: NCT03726892

Last Updated: 2020-06-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-12
• Study Completion Date: 2022-07-01

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

The SYNERGY stent

Group Type: ACTIVE_COMPARATOR

PCI

Intervention Type: DEVICE

Coronary Intervention

Xience

Group Type: ACTIVE_COMPARATOR

PCI

Intervention Type: DEVICE

Coronary Intervention

Interventions

PCI

Coronary Intervention

Intervention Type: DEVICE

Eligibility Criteria

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

1. When the follow-up after 12 months is considered difficult (the patient's residence should also be considered)

2. When there is no obvious ACS finding in angiography (decisions should be left to operator)

3. Patients with shock

4. Patients whose culprit lesion is the left main coronary trunk

5. Lesion with the reference vascular diameter of <2.0 mm or ≥4.5 mm visually

6. AMI that occurred newly at the site where a stent has already been placed

7. Chronic renal failure in which the serum creatinine concentration at visit is ≥2.0 mg/dL

8. Patients undergoing hemodialysis

9. Tumor-bearing patients whose life prognosis is expected to be within 2 years

10. Patients for whom the surgical operation requiring withdrawal of antiplatelet drug is scheduled within 3 months

11. Female patients during pregnancy or scheduled to be pregnant

12. Patients with a past history of the side effect of aspirin, clopidogrel or prasugrel (when the patient is confirmed for the safety of ticlopidine, this does not apply even if there is the side effect of clopidogrel or prasugrel)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Iwate Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yoshihiro Morino

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yoshihiro Morino, MD

Role: PRINCIPAL_INVESTIGATOR

Iwate Medical University

Locations

Iwate Medical University Hospital

Morioka, , Japan

Countries

Japan

Other Identifiers

IwateMedicalU

Identifier Type: -

Identifier Source: org_study_id