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

February 25, 2009
February 25, 2009
August 2008
July 2009   (final data collection date for primary outcome measure)
Major adverse cardiac event (MACE: cardiac death, myocardial infarction, or target vessel revascularization) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
MACE and stent thrombosis by the criteria of Academic Research Consortium [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Do Cobalt Chrome Stent and Paclitaxel-Eluting Stent Have Equivalent Clinical Result in Non-Complex Lesion?
Do Cobalt Chrome Stent and Paclitaxel-Eluting Stent Have Equivalent Clinical Result in Non-Complex Lesion? (COPE Study): Long-Term Follow-up Study

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
  • 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
  • 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
  • Active Comparator: 1
    Taxus stent group
    Intervention: Device: Taxus stent
  • Active Comparator: 2
    Vision stent group
    Intervention: Device: Vision stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
July 2010
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
Korea, Republic of
 
NCT00852215
2008-07-014
Not Provided
HC Gwon, MD, PhD / Professor, Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Hyeon-Cheol Gwon, MD,PhD Samsung Medical Center
Samsung Medical Center
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP