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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00793312
• Other study ID #: version 3.0 - 12 Nov 2008
• Status: Completed
• Phase: N/A
• First received: November 17, 2008
• Last updated: October 16, 2012
• Start date: November 2007
• Est. completion date: September 2010

Study information

• Verified date: October 2012
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical 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.

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2210
• Est. completion date: September 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Vascular	Medtronic Cardiovascular Asia Pacific

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE		12 Months	Yes