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NOYA CoCr Biodegradable Coating Sirolimus-Eluting Coronary Stent System

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Medfavour (Beijing) Medical Co., Ltd.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01226355
First Posted: October 22, 2010
Last Update Posted: May 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Chinese Academy of Medical Sciences, Fuwai Hospital
Division of Biometrics,National Center for Cardiovascular Diseases,China
Information provided by (Responsible Party):
Medfavour (Beijing) Medical Co., Ltd
  Purpose
A single blind, multi-center, randomized study is preformed to compare NOYA CoCr biodegradable coating sirolimus-eluting stents with Firebird2 drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd. to evaluate the safety and efficacy of NOYA CoCr biodegradable coating sirolimus-eluting stents in treating coronary artery lesions.

Condition Intervention
Coronary Artery Diseases Device: stent

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Trial Program of a Medical Instrument Product

Resource links provided by NLM:


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

Primary Outcome Measures:
  • In-stent late loss at 9-month [ Time Frame: 270 days (±30days) ]
    Standard quantity coronary angiography (QCA) will be conducted at 270 days (±30days) through which the main therapeutic indicator of late luminal loss (LLL) is obtained so as to evaluate the efficacy of tested stents.


Secondary Outcome Measures:
  • MACEs found in follow-up period [ Time Frame: 5 years ]
    Major adverse cardiac events (MACEs) found in following-up period as key indicators to evaluate the safety of stents.


Enrollment: 300
Study Start Date: April 2009
Estimated Study Completion Date: November 2014
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NOYA
implant NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stents Intervention: Device: stent
Device: stent

NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System is manufactured by Medfavour (Beijing) Medical Co., Ltd.

Firebird drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd.

Other Names:
  • NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System
  • Firebird2 drug-eluting stents
Active Comparator: Firebird2
implant Firebird2 drug-eluting stents Intervention: Device: stent
Device: stent

NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System is manufactured by Medfavour (Beijing) Medical Co., Ltd.

Firebird drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd.

Other Names:
  • NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System
  • Firebird2 drug-eluting stents

Detailed Description:
A single blind, multi-center, randomized study is preformed to compare NOYA CoCr biodegradable coating sirolimus-eluting stents with Firebird2 drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd. 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, 90, 180, 270,365 days,2 years,3 years,4 years and 5 years. Especially, standard quantity coronary angiography (QCA) will be conducted at 270 days (±30days) through which the main therapeutic indicator of late luminal loss (LLL) is obtained so as to evaluate the efficacy of tested stents. Major adverse cardiac events (MACEs) 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-75 years, men or unpregnant women;
  2. Angina pectoris patients with non-symptom myocardial ischemia, or patients with obsolete myocardial infarction;
  3. Total of lesion artery ≤2;
  4. Lesion artery ≤30 mm in length, 2.25 to 4.0 mm in diameter (ocular estimate);
  5. Narrow level of lesion artery ≥70% in diameter (ocular estimate);
  6. Amount of same stents implanted in a lesion artery ≤2;
  7. Patients with indications of coronary artery bridging surgery(coronary artery bypass transplant technique);
  8. Patients knowing about the objective of trial, willing to sign a statement of informed consent and join in this trial, and willing to accept follow-up.

Exclusion Criteria:

  1. Patients with acute myocardial infarction in 7 days;
  2. Chronic total occlusion lesions(TIMI 0 grade blood flow prior to implantation), left trunk vessel lesion, three-branch lesions needing treated, fork and bridge vessel lesions of branch vessels whose diameter ≥2.25mm;
  3. Severe calcific lesions and twisted lesions which cannot be pre-expanded, and lesions unsuitable for delivering and expanding stents;
  4. In-stent restenosis lesions;
  5. Patients with stent implantation in his/her coronary artery within recent one year;
  6. Severs heart failure(over NYHA III grade ), or left ventricular ejection fraction(LVEF)< 40%( supersonic inspection or left ventricular radiography );
  7. Kidney functional damage prior to implantation, serum creatinine level>2.0mg/dl;
  8. Patients with hemorrhage tendency, an active digestive ulcer history, a cerebral hemorrhage or subarachnoid hemorrhage history, or cerebral apoplexy within half a year, and these patients who contraindicate against platelet inhibitors and anticoagulant therefore can not bear anticoagulation treatment;
  9. Patients allergic to aspirin, clopidogrel or ticlopidine, heparin, contrast medium, rapamycin and metals;
  10. Patients whose life expectancy less than 12 months;
  11. Patients who are participating in other drugs or medical devices clinical trials;
  12. Patients who can not comply with the clinical trial protocol;
  13. Patients having a heart transplant.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01226355


Locations
China
Fuwai Hospital, National Center for Cardiovascular Diseases
Beijing, China, 100037
Sponsors and Collaborators
Medfavour (Beijing) Medical Co., Ltd
Chinese Academy of Medical Sciences, Fuwai Hospital
Division of Biometrics,National Center for Cardiovascular Diseases,China
Investigators
Principal Investigator: Runlin Gao, Professor Fu Wai Hospital, National Center for Cardiovascular Diseases,China
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medfavour (Beijing) Medical Co., Ltd
ClinicalTrials.gov Identifier: NCT01226355     History of Changes
Other Study ID Numbers: FW2009-183
First Submitted: October 21, 2010
First Posted: October 22, 2010
Last Update Posted: May 22, 2012
Last Verified: May 2012

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
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs