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

NCT ID: NCT00793312

Last Updated: 2012-10-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2210 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2010-09-30

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiovascular Asia Pacific

INDUSTRY

Sponsor Role: collaborator

Medtronic Vascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiyan Chen, Professor

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial People's Hospital

Yaling Han, Professor

Role: PRINCIPAL_INVESTIGATOR

Shenyang North Hospital

Yong Huo, Professor

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Weimin Wang, Professor

Role: PRINCIPAL_INVESTIGATOR

Beijing People's Hospital

Bo Xu, Director

Role: PRINCIPAL_INVESTIGATOR

Fu Wai Hospital, Beijing, China

Other Identifiers

version 3.0 - 12 Nov 2008

Identifier Type: -

Identifier Source: org_study_id