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ComparisiOn of Neointimal coVerage betwEen ZES and EES Using OCT at 3 Months (COVER OCT-II)

This study has been completed.
Information provided by (Responsible Party):
Jung-Sun Kim, Yonsei University Identifier:
First received: March 22, 2010
Last updated: January 26, 2012
Last verified: January 2012
This study try to 1) evaluate the neointimal coverage and malapposition at 3 month after new zotarolimus eluting stent (Endeavor resolute) and everolimus eluting stent (Xience) implantation and 2) compare them between ZES resolute and EES at 3 months (early period) after stent implantation.

Condition Intervention Phase
Coronary Artery Disease
Device: ZES resolute (Endeavor Resolute)
Device: EES (Xience)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
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 3 Months

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • The rate of neointimal coverage between ZES resolute and EES at 3 months after stent implantation by OCT. [ Time Frame: 3 months after stent implantation ]

Secondary Outcome Measures:
  • Neointimal growth between ZES resolute and EES at 3 months after stent by OCT. [ Time Frame: 3 months after stent implantation ]
  • Early malapposition just after stent implantation and late malapposition at 3 months after stent implantaiton between ZES resolute and EES by OCT. [ Time Frame: 3 months after stent implantation ]

Enrollment: 40
Study Start Date: August 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ZES resolute (Endeavor Resolute) Device: ZES resolute (Endeavor Resolute)
2nd generation drug eluting stent, which is coated with zotarolimus
Other Name: Endeavor resolute
Active Comparator: EES (Xience) Device: EES (Xience)
2nd generation drug eluting stent, which is coated with everolimus
Other Name: Xience

  Show Detailed Description


Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Significant coronary de novo lesion (> 70% by quantitative angiographic analysis)
  • Patients with stable angina pectoris who are considered for coronary revascularization.
  • Reference vessel diameter of 2.5 to 3.5 mm by operator assessment

Exclusion Criteria:

  • Acute coronary syndrome
  • Contraindication to anti-platelet agents
  • Proximal leison within 15 mm from ostium
  • Treated with any DES within 1 year at other vessel
  • Creatinine level 2.0 mg/dL or ESRD
  • Severe hepatic dysfunction (3 times normal reference values)
  • Pregnant women or women with potential childbearing
  • Complex lesion morphologies (aorto-ostial, unprotected Left main, chronic total occlusion)
  • Target lesion is vein graft lesion
  • Reference vessel < 2.5 mm or > 4.0mm diameter by visual
  Contacts and Locations
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Please refer to this study by its identifier: NCT01091740

Korea, Republic of
Dongsan Medical Center, Keimyung University College of Medicine
Daegu, Korea, Republic of, 700-712
Division of Cardiology, Cardiovascular Hospital, Yonsei University
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Principal Investigator: Jung-Sun Kim, MD, Ph D Division of Cardiology, Cardiovascular Hospital, Yonsei University
  More Information

Responsible Party: Jung-Sun Kim, Assistant Professor, Yonsei University Identifier: NCT01091740     History of Changes
Other Study ID Numbers: 1-2009-0010
Study First Received: March 22, 2010
Last Updated: January 26, 2012

Keywords provided by Yonsei University:
Drug eluting stent
Tomography, optical coherence

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on March 30, 2017