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NOYA CoCr Biodegradable Coating Sirolimus-Eluting Coronary Stent System

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Fuwai Hospital,National Center for Cardiovascular Diseases,China
Division of Biometrics,National Center for Cardiovascular Diseases,China
Information provided by (Responsible Party):
Medfavour (Beijing) Medical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01226355
First received: October 21, 2010
Last updated: May 20, 2012
Last verified: May 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Trial Program of a Medical Instrument Product

Resource links provided by NLM:

U.S. FDA Resources

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) ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226355

Locations
China
Fuwai Hospital, National Center for Cardiovascular Diseases
Beijing, China, 100037
Sponsors and Collaborators
Medfavour (Beijing) Medical Co., Ltd
Fuwai Hospital,National Center for Cardiovascular Diseases,China
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

No publications provided by Medfavour (Beijing) Medical Co., Ltd

Additional 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
Study First Received: October 21, 2010
Last Updated: May 20, 2012
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
 Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on June 18, 2013