Do Cobalt Chrome Stent and Paclitaxel-Eluting Stent Have Equivalent Clinical Result in Non-Complex Lesion? (COPE)
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|ClinicalTrials.gov Identifier: NCT00852215|
Recruitment Status : Unknown
Verified February 2009 by Samsung Medical Center.
Recruitment status was: Recruiting
First Posted : February 26, 2009
Last Update Posted : February 26, 2009
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: Taxus stent Device: Vision stent||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2008|
|Estimated Primary Completion Date :||July 2009|
|Estimated Study Completion Date :||July 2010|
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
- Major adverse cardiac event (MACE: cardiac death, myocardial infarction, or target vessel revascularization) [ Time Frame: 1 year ]
- MACE and stent thrombosis by the criteria of Academic Research Consortium [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00852215
|Contact: Hyeon-Cheol Gwon, MD,PhDemail@example.com|
|Contact: Young Bin Song, MDfirstname.lastname@example.org|
|Korea, Republic of|
|Samsung Medical Center||Recruiting|
|Seoul, Korea, Republic of, 135-710|
|Contact: Hyoen-Cheol Gwon, MD,PhD 82-2-3410-3418 email@example.com|
|Contact: Young Bin Song, MD 82-2-3410-3419 firstname.lastname@example.org|
|Principal Investigator:||Hyeon-Cheol Gwon, MD,PhD||Samsung Medical Center|