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

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Jung-Sun Kim, Yonsei University
ClinicalTrials.gov Identifier:
NCT01091740
First received: March 22, 2010
Last updated: January 26, 2012
Last verified: January 2012
  Purpose

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
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 3 Months

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Neointimal growth between ZES resolute and EES at 3 months after stent by OCT. [ Time Frame: 3 months after stent implantation ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   20 Years to 90 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01091740

Locations
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
Medtronic
Investigators
Principal Investigator: Jung-Sun Kim, MD, Ph D Division of Cardiology, Cardiovascular Hospital, Yonsei University
  More Information

No publications provided

Responsible Party: Jung-Sun Kim, Assistant Professor, Yonsei University
ClinicalTrials.gov Identifier: NCT01091740     History of Changes
Other Study ID Numbers: 1-2009-0010
Study First Received: March 22, 2010
Last Updated: January 26, 2012
Health Authority: Korea: Food and Drug Administration

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
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014