Safety and Efficacy Study of NOYA Sirolimus-Eluting Stent to Treat Coronary Artery Disease

Not Applicable

• Conditions: Coronary Artery Disease
• Interventions: Device: NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System

• Registration Number: NCT02216058
• Lead Sponsor: Medfavour (Beijing) Medical Co., Ltd

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.

Study Timeline

• Study Start: 2013-04
• Status Verified: 2014-08
• Study First Submitted: 2014-08-11
• Study First Submitted QC: 2014-08-12
• Last Update Submitted: 2014-08-12
• Study First Posted: 2014-08-13
• Last Update Posted: 2014-08-13
• Primary Completion: 2017-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NOYA	NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System	NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System

Primary Outcome Measures

Name	Time	Method
TLF(Target Lesion Failure)	24 months

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China