Do Cobalt Chrome Stent and Paclitaxel-Eluting Stent Have Equivalent Clinical Result in Non-Complex Lesion? (COPE)
Recruitment status was Recruiting
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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 |
- Major adverse cardiac event (MACE: cardiac death, myocardial infarction, or target vessel revascularization) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- 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 |
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| 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 | |
| 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 | |
| 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 |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013