Clinical trial NCT02216058: Safety and Efficacy Study of NOYA Sirolimus-Eluting Stent to Treat Coronary Artery Disease
Official title: A Prospective, Multicenter Trial of NOYA Sirolimus-Eluting Stent With Biodegradable Coating in Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Medfavour (Beijing) Medical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2014-08-13
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 judged by inclusion and exclusion standards will be preformed stent implantation, and after that all patients will be clinically followed up at 30, 180, 365 days,2 years,3 years,4 years and 5 years. Target Lesion Failure (TLF) found in following-up period as key indicators to evaluate the safety of stents. The arrangement, conclusion and statistical analysis of trial data including clinography and angiography will be fulfilled by independent Data Management Center(DMC) and radiography core laboratory.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: TLF(Target Lesion Failure)
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chines PLA General Hospital
name: Yundai Chen, Dr.
role: PRINCIPAL_INVESTIGATOR
References: