NCT00894062

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_4 coronary-artery-disease

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 6, 2009

Completed
Last Updated

March 24, 2010

Status Verified

July 1, 2009

First QC Date

May 5, 2009

Last Update Submit

March 23, 2010

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Evaluation of neointimal coverage of ZES resolute (Endeavor® resolute) and EES Xience®) by OCT.

    at 9 months after stent implantation

Secondary Outcomes (2)

  • Investigate the relationship between initial lesion and neointimal coverage and malapposition at 9 months.

    9 months after stent implantation

  • Comparison of neointimal growth between ZES resolute and EES at 9 months.

    9 months after stent implantation

Study Arms (2)

1

ACTIVE COMPARATOR

ZES resolute (Endeavor® resolute)

Device: Zotarolimus eluting stent (Endeavor resoulte - ZES resolute)

2

ACTIVE COMPARATOR

EES (Xience®)

Device: Everolimus eluting stent (Xience - EES)

Interventions

Zotarolimus eluting stent (Endeavor resoulte - ZES resolute)DEVICE

Zotarolimus eluting stent (ZES)

1
Everolimus eluting stent (Xience - EES)DEVICE

Everolimus eluting stent (EES)

2

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Significant coronary de novo lesion (\> 70% by quantitative angiographic analysis)
  • Patients with stable or acute coronary syndrome considered for coronary revascularization
  • Reference vessel diameter of 2.5 to 3.5 mm by operator assessment

You may not qualify if:

  • Proximal lesion within 15 mm from ostium
  • Different DES in other vessel simultaneously
  • Creatinine level 2.0 mg/dL or ESRD
  • Severe hepatic dysfunction (3 times normal reference values)
  • Pregnant women or women with potential childbearing
  • Life expectancy 1 year
  • Complex lesion morphologies (aorto-ostial, bifurcation with \> 2.0 mm side branch, unprotected left main, thrombus, severe calcification, chronic total occlusion)
  • Target lesion is vein graft lesion
  • Reference vessel \< 2.5 mm or \> 4.0 mm diameter by visual
  • Long lesion that require more than two stents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dongsan Medical Center, Keimyung University

Daegu, 700-712, South Korea

Location

Severance Hospital, Yonsei University

Seoul, 120-752, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (1)

  • Kim JS, Kim BK, Jang IK, Shin DH, Ko YG, Choi D, Hong MK, Cho YK, Nam CW, Hur SH, Choi JH, Song YB, Hahn JY, Choi SH, Gwon HC, Jang Y. ComparisOn of neointimal coVerage betwEen zotaRolimus-eluting stent and everolimus-eluting stent using Optical Coherence Tomography (COVER OCT). Am Heart J. 2012 Apr;163(4):601-7. doi: 10.1016/j.ahj.2011.10.016.

    PMID: 22520526DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Jung-Sun Kim, MD, Ph D

    Division of Cardiology, Cardiovascular Hospital, Yonsei University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 5, 2009

First Posted

May 6, 2009

Study Start

December 1, 2008

Last Updated

March 24, 2010

Record last verified: 2009-07

Locations

KR(3)