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

NCT ID: NCT00852215

Last Updated: 2009-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Coronary Artery Disease

Keywords

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Angioplasty, Transluminal, Percutaneous Coronary Paclitaxel-eluting stent Vision stent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Taxus stent group

Group Type ACTIVE_COMPARATOR

Taxus stent

Intervention Type DEVICE

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

2

Vision stent group

Group Type ACTIVE_COMPARATOR

Vision stent

Intervention Type DEVICE

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

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Samsung Medical Center

Principal Investigators

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Hyeon-Cheol Gwon, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hyeon-Cheol Gwon, MD,PhD

Role: CONTACT

Phone: 82-2-3410-3418

Email: [email protected]

Young Bin Song, MD

Role: CONTACT

Phone: 82-2-3410-3419

Email: [email protected]

Facility Contacts

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Hyoen-Cheol Gwon, MD,PhD

Role: primary

Young Bin Song, MD

Role: backup

Other Identifiers

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2008-07-014

Identifier Type: -

Identifier Source: org_study_id