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

NCT00852215 | Unknown Phase 4

• 1 other identifier: 2008-07-014
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac event (MACE: cardiac death, myocardial infarction, or target vessel revascularization)

  1 year

Secondary Outcomes (1)

• MACE and stent thrombosis by the criteria of Academic Research Consortium

  2 years

Study Arms (2)

1

ACTIVE COMPARATOR

Taxus stent group

Device: Taxus stent

2

ACTIVE COMPARATOR

Vision stent group

Device: Vision stent

Interventions

Taxus stent 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

1

Vision stent 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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Hyeon-Cheol Gwon, MD,PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyeon-Cheol Gwon, MD,PhD

CONTACT

82-2-3410-3418; hcgwon@skku.edu

Young Bin Song, MD

CONTACT

82-2-3410-3419; youngbin.song@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 25, 2009
• First Posted: February 26, 2009
• Study Start: August 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2010
• Last Updated: February 26, 2009

Record last verified: 2009-02

Locations

KR (1)