Comparison of Neointimal Coverage Between Zotarolimus Eluting Stent and Everolimus Eluting Stent (COVER OCT)

This study has been completed.
Sponsor:
Collaborator:
Medtronic Vascular
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT00894062
First received: May 5, 2009
Last updated: March 23, 2010
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Device: Zotarolimus eluting stent (Endeavor resoulte - ZES resolute)
Device: Everolimus eluting stent (Xience - EES)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ComparisiOn of Neointimal coVerage betwEen zotaRolimus Eluting Stent and Everolimus Eluting Stent Using Optical Coherence Tomography at 9 Months (COVER OCT)

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Evaluation of neointimal coverage of ZES resolute (Endeavor® resolute) and EES Xience®) by OCT. [ Time Frame: at 9 months after stent implantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Investigate the relationship between initial lesion and neointimal coverage and malapposition at 9 months. [ Time Frame: 9 months after stent implantation ] [ Designated as safety issue: No ]
  • Comparison of neointimal growth between ZES resolute and EES at 9 months. [ Time Frame: 9 months after stent implantation ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: December 2008
Arms Assigned Interventions
Active Comparator: 1
ZES resolute (Endeavor® resolute)
Device: Zotarolimus eluting stent (Endeavor resoulte - ZES resolute)
Zotarolimus eluting stent (ZES)
Active Comparator: 2
EES (Xience®)
Device: Everolimus eluting stent (Xience - EES)
Everolimus eluting stent (EES)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • The criteria for exclusion were contraindication to anti-platelet agents
  • 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00894062

Locations
Korea, Republic of
Dongsan Medical Center, Keimyung University
Daegu, Korea, Republic of, 700-712
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Severance Hospital, Yonsei University
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Medtronic Vascular
Investigators
Principal Investigator: Jung-Sun Kim, MD, Ph D Division of Cardiology, Cardiovascular Hospital, Yonsei University
  More Information

No publications provided by Yonsei University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kim, Jung-Sun, MD, Ph D, Severance Hospital, Yonsei University
ClinicalTrials.gov Identifier: NCT00894062     History of Changes
Other Study ID Numbers: 4-2008-0483
Study First Received: May 5, 2009
Last Updated: March 23, 2010
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 26, 2014