Status:
COMPLETED
China Endeavor Registry: A Registry With The Endeavor Zotarolimus Eluting Coronary Stent in China
Lead Sponsor:
Medtronic Vascular
Collaborating Sponsors:
Medtronic Cardiovascular Asia Pacific
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
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 popu...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
2210 Patients enrolled
Trial Details
Trial ID
NCT00793312
Start Date
November 1 2007
End Date
September 1 2010
Last Update
October 17 2012
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