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

This study has been completed.
Sponsor:
Collaborator:
Medtronic Cardiovascular Asia Pacific
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT00793312
First received: November 17, 2008
Last updated: October 16, 2012
Last verified: October 2012
  Purpose

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
Coronary Artery Disease

Study Type: Observational
Study Design: 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

Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:
  • MACE [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]

Enrollment: 2210
Study Start Date: November 2007
Study Completion Date: September 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.
  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: NCT00793312

Sponsors and Collaborators
Medtronic Vascular
Medtronic Cardiovascular Asia Pacific
Investigators
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 Beijing Fuwai Hospital
  More Information

No publications provided

Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT00793312     History of Changes
Other Study ID Numbers: version 3.0 - 12 Nov 2008
Study First Received: November 17, 2008
Last Updated: October 16, 2012
Health Authority: China: Ethics Committee

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

ClinicalTrials.gov processed this record on September 30, 2014