Coronary Artery DiseaseENDEAVOR OCTNCT00815139
Evaluation of Zotarolimus Eluting Stent at 3 Months Using Optical Coherence Tomography
An observational study of Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2008to Nov 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who present to the cath lab for non-emergent percutaenous coronary intervention and stenting are eligible for participation
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Cardiology, Cardiovascular Hospital, Yonsei University
Seoul, 120-752
About this study
Official title: Evaluation in 3 moNths Duration of nEointimAl coVerAge After zOtaRolimus-Eluting Stent Implantation by Optical Coherence Tomography (ENDEAVOR OCT)
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ZES group | Groups who were treated with zotarolimus eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2008 (estimated)
- Study startFeb 2008
- Primary completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Investigators
- Yangsoo Jang, MD, Ph D, Principal investigator, Division of Cardiology, Cardiovascular Hospital, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815139
- Sponsor's protocol ID
- 4-2007-0409
- Acronym
- ENDEAVOR OCT
- Status last verified
- Dec 2008
- First submitted
- 26 Dec 2008
- Last updated
- 29 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20129551
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation in 3 moNths Duration of nEointimAl coVerAge After zOtaRolimus-Eluting Stent Implantation by Optical Coherence Tomography (ENDEAVOR OCT)
- ClinicalTrials.gov ID
- NCT00815139
- Acronym / sponsor ID
- ENDEAVOR OCT / 4-2007-0409
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, stent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Nov 2008 (actual)
- First posted
- 29 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ZES group | – | –Groups who were treated with zotarolimus eluting stent |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who present to the cath lab for non-emergent percutaenous coronary intervention and stenting are eligible for participation
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2008.
- Derived from this study: PubMed 20129551Kim 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.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yangsoo Jang, MD, Ph D principal investigator
Division of Cardiology, Cardiovascular Hospital, Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00815139, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2008.