MedTrace Logo

Comparison of Neointimal Coverage Between Zotarolimus Eluting Stent and Everolimus Eluting Stent

NCT00894062 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2010-03-24

No results posted yet for this study

Summary

Stent thrombosis is an important issue in drug eluting stents. Incomplete endothelial coverage and neointimal coverage over strut after drug eluting stent (DES) implantation could be a possible cause of stent thrombosis. Therefore, theoretically dual antiplatelet therapy should be continued to prevent the stent thrombosis until complete reendothelialization. But, detection of endothelial coverage over stent is not possible with the available intravascular devices in clinical practice. Among currently available intravascular devices, intravascular optical coherence tomography (OCT) could give a more clear identification for a thin layer of neointima with high-resolution (10-20 μm) compared to intravascular ultrasound (100-150 μm). Previous OCT studies showed the significant different pattern of neointimal coverage between bare metal stent (BMS) and DES. In the investigators' experience, there were also some differences in neointimal coverage among the DESs, especially zotarolimus eluting stent (ZES). ZES has been known to be associated with significantly more neointimal coverage than SES at 8 months intravascular ultrasound (IVUS). Both everolimus eluting stent (EES) and ZES resolute were recently introduced. The efficacy to suppress the neointimal growth for ZES resolute and EES might be improved, but safety for neointimal coverage needs to evaluate in human coronary artery. Therefore, this study will investigate the pattern of neointimal coverage over stent in ZES resolute and EES at 9 months after stent implantation.

Conditions

Interventions

DEVICE

Zotarolimus eluting stent (Endeavor resoulte - ZES resolute)

Zotarolimus eluting stent (ZES)

DEVICE

Everolimus eluting stent (Xience - EES)

Everolimus eluting stent (EES)

Sponsors & Collaborators

  • Medtronic Vascular

    collaborator INDUSTRY

  • Yonsei University

    lead OTHER

Principal Investigators

  • Jung-Sun Kim, MD, Ph D · Division of Cardiology, Cardiovascular Hospital, Yonsei University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT00894062 on ClinicalTrials.gov