Evaluation of Zotarolimus Eluting Stent at 3 Months Using Optical Coherence Tomography

NCT00815139 | Completed

• 1 other identifier: 4-2007-0409
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Neointimal coverage over stent strut is important for preventing the stent thrombosis. But, there is no data for the duration of complete formation of neointima om zotarolimus eluting stent (ZES). Previously the investigational observational data at 9 months showed most of stent strut was covered with neointima. Therefore, the investigators investigated the evaluation of neointimal coverage on 3 months after ZES implantation using novel OCT system, which is powerful intravascular imaging system having the higher resolution power.

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease, stent

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is to evaluate the neointimal coverage of Zotarolimus (Endeavor®) eluting stent (ZES) in 3 month after stent implantation by Optical coherence tomography.

  3 months

Secondary Outcomes (1)

• to compare the difference in neointimal coverage between ACS and non-ACS and to compare the difference in detection of neointimal coverage between OCT and IVUS at 3 months.

  3 months

Study Arms (1)

ZES group

Groups who were treated with zotarolimus eluting stent

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who present to the cath lab for non-emergent percutaenous coronary intervention and stenting are eligible for participation

You may qualify if:

• Significant coronary de novo lesion ( \> 70% by quantitative angiographic analysis)
• Patients with stable or acute coronary syndrome considered for coronary revascularization.
• Non-emergent conditions
• Reference vessel diameter of 2.75 to 4.0 mm by operator assessment

You may not qualify if:

• ST elevation MI requiring primary PCI
• Proximal lesion within 15 mm from ostium
• Prior insertion of other DES in any vessel
• Creatinine level more than 2.0mg/dL or ESRD
• Severe hepatic dysfunction (more than 3 times normal reference values)
• Pregnant women or women with potential childbearing
• Life expectancy less than 1 year
• Complex lesion morphologies (aorto-ostial, bifurcation with \>2.0 mm side branch, unprotected Left main, thrombus, severe calcification, chronic total occlusion)
• Target lesion is vein graft lesion
• Reference vessel \<2.5 mm or \>4.0 mm diameter by visual estimation
• Long lesion that require more than two stents

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Division of Cardiology, Cardiovascular Hospital, Yonsei University

Seoul, 120-752, South Korea

Location

Related Publications (1)

• Kim JS, Jang IK, Fan C, Kim TH, Kim JS, Park SM, Choi EY, Lee SH, Ko YG, Choi D, Hong MK, Jang Y. Evaluation in 3 months duration of neointimal coverage after zotarolimus-eluting stent implantation by optical coherence tomography: the ENDEAVOR OCT trial. JACC Cardiovasc Interv. 2009 Dec;2(12):1240-7. doi: 10.1016/j.jcin.2009.10.006.

  PMID: 20129551 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood

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

• Yangsoo Jang, MD, Ph D

  Division of Cardiology, Cardiovascular Hospital, Yonsei University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 26, 2008
• First Posted: December 29, 2008
• Study Start: February 1, 2008
• Primary Completion: November 1, 2008
• Last Updated: December 29, 2008

Record last verified: 2008-12

Locations

KR (1)