Do Cobalt Chrome Stent and Paclitaxel-Eluting Stent Have Equivalent Clinical Result in Non-Complex Lesion? (COPE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00852215
First received: February 25, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

We sought to evaluate the long-term safety and efficacy of drug-eluting stent in large vessels compared with bare metal stent.


Condition Intervention Phase
Coronary Artery Disease
Device: Taxus stent
Device: Vision stent
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: Do Cobalt Chrome Stent and Paclitaxel-Eluting Stent Have Equivalent Clinical Result in Non-Complex Lesion? (COPE Study): Long-Term Follow-up Study

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Major adverse cardiac event (MACE: cardiac death, myocardial infarction, or target vessel revascularization) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • MACE and stent thrombosis by the criteria of Academic Research Consortium [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: August 2008
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Taxus stent group
Device: Taxus stent
Stenting with Paclitaxel-eluting coronary stent system for coronary lesions with > 50% diameter stenosis with ischemic symptoms or positive functional study, or > 70% diameter stenosis without ischemic symptoms or positive functional study
Active Comparator: 2
Vision stent group
Device: Vision stent
Stenting with VISION coronary stent system for coronary lesions with > 50% diameter stenosis with ischemic symptoms or positive functional study, or > 70% diameter stenosis without ischemic symptoms or positive functional study

Detailed Description:

Drug-eluting stent (DES) has been proved to reduced restenosis rate dramatically compared to bare metal stent (BMS). However, the long-term safety of DES is still uncertain. Recent meta-analysis showed that very late stent thrombosis rate was higher in DES group although overall mortality was similar between 2 groups.

The safety issue of DES was first suggested in the BASKET-LATE study, which compared cobalt chromium alloy BMS (VISION®, Guidant, USA) with sirolimus- or paclitaxel-coated DES. The study showed a significantly higher rate of death or myocardial infarction in the DES group between 7 and 18 month after the procedure (BMS 1.3%, DES 4.9%, p=0.01). Moreover, benefit to reduce target vessel revascularization was not found and there was even the possibility of late harm in patients treated with DES in large native vessels.

We perform a multicenter prospective randomized study comparing paclitaxel-eluting stent with cobalt chromium stent several years, originally to see whether major adverse cardiac event is significantly lower in DES compared to thin-strut BMS in the non-complex lesion subset. In this article, we would like to investigate the 2-year clinical events in DES and BMS groups.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Angiographically proved significant stenosis in native coronary artery (> 50% diameter stenosis with ischemic symptoms or positive functional study, or > 70% diameter stenosis without ischemic symptoms or positive functional study)
  • planned target lesion number =< 2
  • reference diameter 2.75 - 4.0 mm
  • lesions can be fully covered by one 28 mm or shorter stent

Exclusion Criteria:

  • unprotected left main coronary disease with more than 50% stenosis or planned left main angioplasty
  • ostial target lesion (within 5 mm of ostium)
  • angiographic evidence of thrombus within target lesion
  • calcified lesions which cannot be successfully predilated
  • instent restenosis
  • multi-vessel intervention more than 2 lesions
  • atherectomy is planned before stenting
  • bifurcation lesion that needs side branch ballooning or stenting
  • Severe left ventricular dysfunction with echocardiographic ejection fraction less than 30%
  • ST-elevation myocardial infarction within the preceding 72 hours
  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: NCT00852215

Contacts
Contact: Hyeon-Cheol Gwon, MD,PhD 82-2-3410-3418 hcgwon@skku.edu
Contact: Young Bin Song, MD 82-2-3410-3419 youngbin.song@gmail.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Hyoen-Cheol Gwon, MD,PhD    82-2-3410-3418    hcgwon@skku.edu   
Contact: Young Bin Song, MD    82-2-3410-3419    youngbin.song@gmail.com   
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Hyeon-Cheol Gwon, MD,PhD Samsung Medical Center
  More Information

No publications provided

Responsible Party: HC Gwon, MD, PhD / Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00852215     History of Changes
Other Study ID Numbers: 2008-07-014
Study First Received: February 25, 2009
Last Updated: February 25, 2009
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Angioplasty, Transluminal, Percutaneous Coronary
Paclitaxel-eluting stent
Vision stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014