Safety and Efficacy Study of NOYA Sirolimus-Eluting Stent to Treat Coronary Artery Disease
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
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.
Sites / Locations
- Chinese PLA General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NOYA
Arm Description
NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System
Outcomes
Primary Outcome Measures
TLF(Target Lesion Failure)
Secondary Outcome Measures
Full Information
NCT ID
NCT02216058
First Posted
August 11, 2014
Last Updated
August 12, 2014
Sponsor
Medfavour (Beijing) Medical Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT02216058
Brief Title
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
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medfavour (Beijing) Medical Co., Ltd
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NOYA
Arm Type
Experimental
Arm Description
NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System
Intervention Type
Device
Intervention Name(s)
NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System
Primary Outcome Measure Information:
Title
TLF(Target Lesion Failure)
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yundai Chen, Dr.
Organizational Affiliation
Chines PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yundai Chen, Dr.
Phone
010-55499209
Email
cyundai@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Yundai Chen, Dr.
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of NOYA Sirolimus-Eluting Stent to Treat Coronary Artery Disease
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