CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 461 enrolled
Drug / intervention
Everolimus eluting stent +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01347554
NCT01347554Phase 4Completed

Comparison of the Efficacy of Everolimus-Eluting Versus Zotarolimus-Eluting Stent for Coronary Lesions in Acute Myocardial Infarction

Yonsei University·interventional·Posted May 4, 2011·Updated Sep 29, 2014

In Brief

A Phase 4 clinical trial evaluating Everolimus eluting stent and Zotarolimus eluting stent for Myocardial Infarction. Completed, enrolled 461 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea
CollaboratorsMedtronic

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 4, 2011
Enrollment StartJan 1, 2009
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 15.2 years ago

Interventions

Everolimus eluting stentdevice

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

Zotarolimus eluting stentdevice

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