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

Coronary Artery Disease Clinical Trial

Official title:

A Prospective, Multicenter Trial of NOYA Sirolimus-Eluting Stent With Biodegradable Coating in Patients With Coronary Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02216058
• Other study ID #: WR-CT-001
• Status: Recruiting
• Phase: N/A
• First received: August 11, 2014
• Last updated: August 12, 2014
• Start date: April 2013
• Est. completion date: June 2020

Study information

• Verified date: August 2014
• Source: Medfavour (Beijing) Medical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: June 2020
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 = ? 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Medfavour (Beijing) Medical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TLF(Target Lesion Failure)		24 months	No