- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01226355
NOYA CoCr Biodegradable Coating Sirolimus-Eluting Coronary Stent System
Clinical Trial Program of a Medical Instrument Product
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Beijing, China, 100037
- Fuwai Hospital, National Center for Cardiovascular Diseases
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18-75 years, men or unpregnant women;
- Angina pectoris patients with non-symptom myocardial ischemia, or patients with obsolete myocardial infarction;
- Total of lesion artery ≤2;
- Lesion artery ≤30 mm in length, 2.25 to 4.0 mm in diameter (ocular estimate);
- Narrow level of lesion artery ≥70% in diameter (ocular estimate);
- Amount of same stents implanted in a lesion artery ≤2;
- Patients with indications of coronary artery bridging surgery(coronary artery bypass transplant technique);
- 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:
- Patients with acute myocardial infarction in 7 days;
- 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;
- Severe calcific lesions and twisted lesions which cannot be pre-expanded, and lesions unsuitable for delivering and expanding stents;
- In-stent restenosis lesions;
- Patients with stent implantation in his/her coronary artery within recent one year;
- Severs heart failure(over NYHA III grade ), or left ventricular ejection fraction(LVEF)< 40%( supersonic inspection or left ventricular radiography );
- Kidney functional damage prior to implantation, serum creatinine level>2.0mg/dl;
- 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;
- Patients allergic to aspirin, clopidogrel or ticlopidine, heparin, contrast medium, rapamycin and metals;
- Patients whose life expectancy less than 12 months;
- Patients who are participating in other drugs or medical devices clinical trials;
- Patients who can not comply with the clinical trial protocol;
- Patients having a heart transplant.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NOYA
implant NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stents Intervention: 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:
|
Active Comparator: Firebird2
implant Firebird2 drug-eluting stents Intervention: 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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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270 days (±30days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MACEs found in follow-up period
Time Frame: 5 years
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Major adverse cardiac events (MACEs) found in following-up period as key indicators to evaluate the safety of stents.
|
5 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Runlin Gao, Professor, Fu Wai Hospital, National Center for Cardiovascular Diseases,China
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Coronary Artery Disease
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Sirolimus
Other Study ID Numbers
- FW2009-183
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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