Status:
UNKNOWN
A Registry To Evaluate Safety And Effectiveness Of Everolimus Drug Eluting Stent For Coronary Revascularization
Lead Sponsor:
CCRF Consulting Co., Ltd.
Conditions:
Coronary Artery Diseases
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This is a prospective, multi-center registry to evaluate safety and effectiveness of the Everolimus Drug Eluting Stent for treatment coronary revascularization in Chinese patients with long lesion, sm...
Detailed Description
Study Device:The XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V EECSS or XIENCE V stent system) is a device/drug combination product consisting of either the MULTI-LINK VISION® Coronary ...
Eligibility Criteria
Inclusion
- The patient must be ≥18 of age; male or (non-pregnant and non-breast feeding) female.
- Diagnosis of stable angina, unstable angina or silent ischemia (evidence of myocardial ischemia).
- Target lesion is at least length ≥ 25mm (visual estimate); or the number of target lesion is ≥ 2; or target vessel diameter ≤ 2.75mm.
- At least one target lesion with a diameter stenosis ≥70% (visual estimate)
- Acceptable candidate for CABG;
- The patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written Notice of Informed Consent, appropriate Ethics Committee(EC); and the patient is willing to comply with specified follow-up evaluations.
Exclusion
- Patients have evidence of an Acute Myocardial Infarction within a week prior to the index procedure.
- Patient has congenital heart disease, severe valve dysfunction, bridge vascular disease, severe heart failure (NYHA ≥ Ⅲ level), or left ventricular ejection fraction ≤ 30%.
- Patient has undergone previous stenting anywhere within the previous 1 year.
- Patient has a preoperative renal dysfunction: serum creatinine\> 2.0mg/dl (176.82umol / L).
- Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated or in which patient will not be able to comply with dual antiplatelet therapy for at least 1 year;
- Patient has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, Prasugrel, stainless steel alloy, cobalt chromium, rapamycin, styrene-butylene-styrene or poly-lactic acid (PLA) polymer, and/or contrast sensitivity that cannot be adequately premedicated; Patient is allergic to contrast agent Sirolimus.
- Patient has other medical illness (e.g., cancer, known malignancy , congestive heart failure, organ transplant recipient or candidate) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy is less than 12 months.
- Currently participating in another investigational drug or device study or patient in inclusion in another investigational drug or device study during follow-up
- Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study; Patient has poor compliance with the judgment of the investigator and can not complete the study as required.
- Patient who had heart transplant.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2013
Estimated Enrollment :
1900 Patients enrolled
Trial Details
Trial ID
NCT01157455
Start Date
May 1 2010
End Date
June 1 2013
Last Update
July 12 2010
Active Locations (1)
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1
Fuwai Hospital
Beijing, China