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)

NCT03726892 | Unknown

• 1 other identifier: IwateMedicalU
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 2-weeks strut coverage rate by FD-OCT

  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.

  2-weeks

Study Arms (2)

The SYNERGY stent

ACTIVE COMPARATOR

Device: PCI

Xience

ACTIVE COMPARATOR

Device: PCI

Interventions

PCI DEVICE

Coronary Intervention

The SYNERGY stent; Xience

Eligibility Criteria

• Age: 20 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Patients for whom the surgical operation requiring withdrawal of antiplatelet drug is scheduled within 3 months
• Female patients during pregnancy or scheduled to be pregnant
• 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)

Sponsors & Collaborators

• Iwate Medical University: lead

Study Sites (1)

Iwate Medical University Hospital

Morioka, 020-8505, Japan

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Yoshihiro Morino, MD

  Iwate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 1, 2018
• Study Start: November 12, 2018
• Primary Completion: May 28, 2020
• Study Completion: July 1, 2022
• Last Updated: June 2, 2020

Record last verified: 2020-05

Locations

JP (1)