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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014