Coronary Artery DiseaseNCT00793312
China Endeavor Registry: A Registry With The Endeavor Zotarolimus Eluting Coronary Stent in China
An observational study of Coronary Artery Disease, run by Medtronic Vascular.
Trial summary
The primary objective is to document the acute and mid-term safety and overall clinical performance of the Endeavor(TM) Zotarolimus Eluting Coronary stent system in a "real world" Chinese patient population requiring stent implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 2,210 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Sep 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an indication for coronary stent implantation according to the 'Instructions for Use' of the Endeavor™ Zotarolimus Eluting Coronary Stent System, or at investigators' discretion. All consecutive patients who receive one or more Endeavor™ stents in one or more target lesions should be included.
Who may be able to join
- Patient is > 18 years of age (or minimum age as required by local regulations).
- The patient has consented to participate by signing the "Patient Informed Consent Form" and/or has authorized the collection and release of his medical information by signing the "Patient Data Release Consent Form".
- Patient is suitable for implantation of one or more Endeavor™ Zotaroliums Eluting Coronary Stent System in one or more native artery target lesions.
- Patient indication, lesion length and vessel diameter of the target lesion(s) are according to the Indications for Use' as mentioned in the 'Instructions for Use' that comes with every Endeavor™ Zotarolimus Eluting Coronary Stent System.
- The patient is willing and able to cooperate with registry procedures and required follow up
Who cannot join
- Women with known pregnancy or who are lactating.
- Patients with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, drugs such as zotaroliums, rapamycin, tacrolimus, sirolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media.
- Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated.
- Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon.
- Current medical condition with a life expectancy of less than 12 months.
- The subject is participating in another device or drug study. Subject must have completed the follow-up phase of any previous study at least 30 days prior to enrollment in this trial. The subject may only be enrolled in this Registry once.
- Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this registry.
About this study
Official title: To Evaluate the 'Real World' Clinical Performance of the Medtronic Endeavor™ Zotarolimus Eluting Coronary Stent System in Chinese Patients, A Prospective, Multicenter Registry
The primary objective is to document the acute and mid-term safety and overall clinical performance of the Endeavor(TM) Zotarolimus Eluting Coronary stent system in a "real world" Chinese patient population requiring stent implantation.
To assess the event rate in patient subgroups with specific clinical indications and/or vessel or lesion characteristics.
Read the detailed description
The safety and efficacy of the Endeavor(TM) Zotarolimus Eluting Coronary Stent System has been assessed in a series of studies, e.g. ENDEAVOR I and ENDEAVOR II. The stent is composed of a cobalt alloy and is coated with a proprietary drug compound zotarolimus that is designed to reduce restenosis.
This registry with the Endeavor(TM) Zotarolimus Eluting Coronary Stent System is being initiated 1) to expand the clinical knowledge base by including 'real world'patients in China and 2) to assess the event rate in Chinese patients known to have a higher risk of major adverse cardiac events, for example patients with diabetes mellitus, small vessels and long lesions.
In total the plan is to enroll about 2200 patients from 37 sites.
Follow-up will be one year for the main patients with cohort to collect acute and mid-term follow-up data, but will be extended to two years for certain patient subgroups.
- Conditions
- Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startNov 2007
- Primary completionSep 2009
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic Cardiovascular Asia Pacific
- Responsible party
- Sponsor
- Investigators
- Jiyan Chen, Professor, Principal investigator, Guangdong Provincial People's HospitalYaling Han, Professor, Principal investigator, Shenyang North HospitalYong Huo, Professor, Principal investigator, Peking University First HospitalWeimin Wang, Professor, Principal investigator, Beijing People's HospitalBo Xu, Director, Principal investigator, Fu Wai Hospital, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793312
- Sponsor's protocol ID
- version 3.0 - 12 Nov 2008
- Status last verified
- Oct 2012
- First submitted
- 17 Nov 2008
- Last updated
- 17 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the 'Real World' Clinical Performance of the Medtronic Endeavor™ Zotarolimus Eluting Coronary Stent System in Chinese Patients, A Prospective, Multicenter Registry
- ClinicalTrials.gov ID
- NCT00793312
- Acronym / sponsor ID
- version 3.0 - 12 Nov 2008
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,210 participants (actual)
- Lead sponsor
- Medtronic VascularIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic Cardiovascular Asia Pacific
- Study start
- Nov 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 19 Nov 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.
The primary objective is to document the acute and mid-term safety and overall clinical performance of the Endeavor(TM) Zotarolimus Eluting Coronary stent system in a "real world" Chinese patient population requiring stent implantation.
To assess the event rate in patient subgroups with specific clinical indications and/or vessel or lesion characteristics.
Detailed description
The safety and efficacy of the Endeavor(TM) Zotarolimus Eluting Coronary Stent System has been assessed in a series of studies, e.g. ENDEAVOR I and ENDEAVOR II. The stent is composed of a cobalt alloy and is coated with a proprietary drug compound zotarolimus that is designed to reduce restenosis.
This registry with the Endeavor(TM) Zotarolimus Eluting Coronary Stent System is being initiated 1) to expand the clinical knowledge base by including 'real world'patients in China and 2) to assess the event rate in Chinese patients known to have a higher risk of major adverse cardiac events, for example patients with diabetes mellitus, small vessels and long lesions.
In total the plan is to enroll about 2200 patients from 37 sites.
Follow-up will be one year for the main patients with cohort to collect acute and mid-term follow-up data, but will be extended to two years for certain patient subgroups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an indication for coronary stent implantation according to the 'Instructions for Use' of the Endeavor™ Zotarolimus Eluting Coronary Stent System, or at investigators' discretion. All consecutive patients who receive one or more Endeavor™ stents in one or more target lesions should be included.
Key inclusion criteria (5 listed)
- Patient is > 18 years of age (or minimum age as required by local regulations).
- The patient has consented to participate by signing the "Patient Informed Consent Form" and/or has authorized the collection and release of his medical information by signing the "Patient Data Release Consent Form".
- Patient is suitable for implantation of one or more Endeavor™ Zotaroliums Eluting Coronary Stent System in one or more native artery target lesions.
- Patient indication, lesion length and vessel diameter of the target lesion(s) are according to the Indications for Use' as mentioned in the 'Instructions for Use' that comes with every Endeavor™ Zotarolimus Eluting Coronary Stent System.
- The patient is willing and able to cooperate with registry procedures and required follow up
Key exclusion criteria (7 listed)
- Women with known pregnancy or who are lactating.
- Patients with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, drugs such as zotaroliums, rapamycin, tacrolimus, sirolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media.
- Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated.
- Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon.
- Current medical condition with a life expectancy of less than 12 months.
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
MACE
Time frame: 12 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 17 Oct 2012.
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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.
Jiyan Chen, Professor principal investigator
Guangdong Provincial People's Hospital
Yaling Han, Professor principal investigator
Shenyang North Hospital
Yong Huo, Professor principal investigator
Peking University First Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Medtronic Vascular.
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 5 inclusion and 7 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 17 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
MACE (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2012.