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Efficacy of Everolimus-Eluting Versus Zotarolimus-Eluting Sten for Coronary Lesions in Acute Myocardial Infarction

NCT01347554 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 461

Last updated 2014-09-29

Study results available
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Summary

Most of the previous data regarding the efficacy of the everolimus-eluting stent (EES) was derived from studies comparing EES with bare metal stent (BMS) or EES with paclitaxel-eluting (PES). Although sirolimus-eluting stents (SES) have been shown to be the most efficacious drug regarding inhibition of neointima and late loss, there have been no previous head to head comparisons between EES and zotarolimus-eluting stent (ZES). Both everolimus and sirolimus are macrocyclic lactones that target the mTOR (mammalian target of rapamycin) to reduce vascular smooth muscle proliferation after vessel injury and therefore in principle may show similar results after stenting in humans. Data pooled from the EES arm that received follow up angiography in the SPIRIT III trial and the SES arm in the SIRIUS trial show similar rates of binary restenosis and late loss. However, the stent and polymer platform is not the same between the EES and ZES and it is reported that the EES system has the thinnest stent + polymer thickness (88.6um) of all of the previously KFDA-approved drug-eluting stent (DES). In addition, there are no data available on the efficacy of the EES and ZES in "real world" lesions other than the selected lesions studied in the previous trials, such as acute myocardial infarction.

Conditions

Interventions

DEVICE

Everolimus eluting stent

Comparison of the safety and efficacy between everolimus-eluting stent and zotarolimus-eluting stent resolute

DEVICE

Zotarolimus eluting stent

Comparison of the safety and efficacy between everolimus-eluting stent and zotarolimus-eluting stent resolute

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Yonsei University

    lead OTHER

Principal Investigators

  • Seung-Hwan Lee, MD, PhD · Division of Cardiology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • South Korea

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01347554 on ClinicalTrials.gov