Evaluation of Zotarolimus Eluting Stent at 3 Months Using Optical Coherence Tomography (ENDEAVOR OCT)

This study has been completed.
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT00815139
First received: December 26, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

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.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation in 3 moNths Duration of nEointimAl coVerAge After zOtaRolimus-Eluting Stent Implantation by Optical Coherence Tomography (ENDEAVOR OCT)

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Blood


Enrollment: 30
Study Start Date: February 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
ZES group
Groups who were treated with zotarolimus eluting stent

Detailed Description:

Stent thrombosis is current main issue after introduction of drug-eluting stents and theoretically dual antiplatelet therapy should be continued to prevent the stent thrombosis until complete reendothelization. Currently, AHA/ACC guideline recommend dual antiplatelet should continue at least 3 months in Sirolimus eluting stent (SES) and 6 months in paclitaxel eluting stent (PES), but if possible, suggest to use until 12 months.

Zotarolimus (Endeavor®) eluting stent (ZES) have been recently introduced and focused on reducing concern of safety through the biocompatible polymer and rapid drug elution. ENDEAVOR II trial showed a 0.5 per cent rate of stent thrombosis at 30 days - with no late thrombosis beyond 30 days and no late stent malapposition. In the long term follow up data of Endeavor stent, the two-year clinical results of ENDEAVOR I were impressive, with a low TVF and MACE rate (2% and 3% respectively) with the absence of reported thromboses after day 14. These results speak, especially the lack of stent thrombosis after 14 days, reflect very well on the performance and safety of the ZES.

But, there has been no guideline for the duration of dual antiplatelet therapy in ZES although shorter duration of dual antiplatelet therapy could be safe compared to previous drug-eluting stents. Also, there is no data how long duration might be taken in completion of reendothelialization after ZES implantation in living patients. The most powerful histological predictor of stent thrombosis was endothelial coverage. The best morphometric predictor of LST was the ratio of uncovered to total stent struts. Because the presence of endothelization is not available in in vivo situation and endothelialization is reported to be associated with neointimal coverage of stent, the detection of neointima after stent implantation could be the main issue to predict the stent thrombosis. Recent data in SES using optical coherence tomography (OCT) reported neointimal coverage over a SES at 3-month follow-up is incomplete. The rates of exposed struts and exposed struts with malapposition were 15% and 6%, respectively. These were more frequent in patients with acute coronary syndrome (ACS) than in those with non-ACS (18% vs 13%, p <0.0001; 8% vs 5%, p <0.005, respectively).

Although neointimal coverage could be completely in early period after ZES implantation, there is no data for this finding. Therefore, we investigate 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. This study may provide adequate information on the safety of discontinuation of dual antiplatelet therapy for patients in clinical situations.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • The criteria for exclusion were contraindication to anti-platelet agents
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00815139

Locations
Korea, Republic of
Division of Cardiology, Cardiovascular Hospital, Yonsei University
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Yangsoo Jang, MD, Ph D Division of Cardiology, Cardiovascular Hospital, Yonsei University
  More Information

No publications provided by Yonsei University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yangsoo Jang, Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei Univerisity
ClinicalTrials.gov Identifier: NCT00815139     History of Changes
Other Study ID Numbers: 4-2007-0409
Study First Received: December 26, 2008
Last Updated: December 26, 2008
Health Authority: South Korea: Institutional Review Board

Keywords provided by Yonsei University:
Coronary artery disease, stent

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014