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China Endeavor Registry: A Registry With The Endeavor Zotarolimus Eluting Coronary Stent in China

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00793312
Recruitment Status : Completed
First Posted : November 19, 2008
Last Update Posted : October 17, 2012
Medtronic Cardiovascular Asia Pacific
Information provided by (Responsible Party):
Medtronic Vascular

Brief 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.

To assess the event rate in patient subgroups with specific clinical indications and/or vessel or lesion characteristics.

Condition or disease
Coronary Artery Disease

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.

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Study Type : Observational
Actual Enrollment : 2210 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : November 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2010

Primary Outcome Measures :
  1. MACE [ Time Frame: 12 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00793312

Sponsors and Collaborators
Medtronic Vascular
Medtronic Cardiovascular Asia Pacific
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Principal Investigator: Jiyan Chen, Professor Guangdong Provincial People's Hospital
Principal Investigator: Yaling Han, Professor Shenyang North Hospital
Principal Investigator: Yong Huo, Professor Peking University First Hospital
Principal Investigator: Weimin Wang, Professor Beijing People's Hospital
Principal Investigator: Bo Xu, Director Fu Wai Hospital, Beijing, China
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Responsible Party: Medtronic Vascular Identifier: NCT00793312    
Other Study ID Numbers: version 3.0 - 12 Nov 2008
First Posted: November 19, 2008    Key Record Dates
Last Update Posted: October 17, 2012
Last Verified: October 2012
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases