Status:
UNKNOWN
Safety and Efficacy Study of NOYA Sirolimus-Eluting Stent to Treat Coronary Artery Disease
Lead Sponsor:
Medfavour (Beijing) Medical Co., Ltd
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
A prospective, multicenter study is preformed to evaluate the safety and efficacy of NOYA CoCr biodegradable coating sirolimus-eluting stents in treating coronary artery lesions.
Detailed Description
A prospective, multicenter study is preformed to evaluate the safety and efficacy of NOYA CoCr biodegradable coating sirolimus-eluting stents in treating coronary artery lesions. Appropriate patients ...
Eligibility Criteria
Inclusion
- The patient must be ≥18 of age; male or non-pregnant female.
- Diagnosis of coronary artery disease.
- 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
- 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 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.
- 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 :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2020
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT02216058
Start Date
April 1 2013
End Date
June 1 2020
Last Update
August 13 2014
Active Locations (1)
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1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853