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

Coronary Artery Disease Clinical Trial

— COPE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00852215
• Other study ID #: 2008-07-014
• Status: Recruiting
• Phase: Phase 4
• First received: February 25, 2009
• Last updated: February 25, 2009
• Start date: August 2008
• Est. completion date: July 2010

Study information

• Verified date: February 2009
• Source: Samsung Medical Center
• Contact: Hyeon-Cheol Gwon, MD,PhD
• Phone: 82-2-3410-3418
• Email: hcgwon[@]skku.edu
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac event (MACE: cardiac death, myocardial infarction, or target vessel revascularization)		1 year	Yes
Secondary	MACE and stent thrombosis by the criteria of Academic Research Consortium		2 years	Yes