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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Medfavour (Beijing) Medical Co., Ltd
Sponsor:
Information provided by (Responsible Party):
Medfavour (Beijing) Medical Co., Ltd
ClinicalTrials.gov Identifier:
NCT02216058
First received: August 11, 2014
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Device: NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter Trial of NOYA Sirolimus-Eluting Stent With Biodegradable Coating in Patients With Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by Medfavour (Beijing) Medical Co., Ltd:

Primary Outcome Measures:
  • TLF(Target Lesion Failure) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: April 2013
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NOYA
NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System
Device: NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02216058

Locations
China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Yundai Chen, Dr.    010-55499209    cyundai@medmail.com.cn   
Principal Investigator: Yundai Chen, Dr.         
Sponsors and Collaborators
Medfavour (Beijing) Medical Co., Ltd
Investigators
Principal Investigator: Yundai Chen, Dr. Chines PLA General Hospital
  More Information

No publications provided

Responsible Party: Medfavour (Beijing) Medical Co., Ltd
ClinicalTrials.gov Identifier: NCT02216058     History of Changes
Other Study ID Numbers: WR-CT-001
Study First Received: August 11, 2014
Last Updated: August 12, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014