Safety and Efficacy Study of NOYA Sirolimus-Eluting Stent to Treat Coronary Artery Disease
A Prospective, Multicenter Trial of NOYA Sirolimus-Eluting Stent With Biodegradable Coating in Patients With Coronary Artery Disease
1 other identifier
interventional
2,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable coronary-artery-disease
Started Apr 2013
Longer than P75 for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 11, 2014
CompletedFirst Posted
Study publicly available on registry
August 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedAugust 13, 2014
August 1, 2014
4.2 years
August 11, 2014
August 12, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
TLF(Target Lesion Failure)
24 months
Study Arms (1)
NOYA
EXPERIMENTALNOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Patient has poor compliance with the judgment of the investigator and can not complete the study as required.
- Patient who had heart transplant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yundai Chen, Dr.
Chines PLA General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2014
First Posted
August 13, 2014
Study Start
April 1, 2013
Primary Completion
June 1, 2017
Study Completion
June 1, 2020
Last Updated
August 13, 2014
Record last verified: 2014-08