Status:
UNKNOWN
NOYA CoCr Biodegradable Coating Sirolimus-Eluting Coronary Stent System
Lead Sponsor:
Medfavour (Beijing) Medical Co., Ltd
Collaborating Sponsors:
Chinese Academy of Medical Sciences, Fuwai Hospital
Division of Biometrics,National Center for Cardiovascular Diseases,China
Conditions:
Coronary Artery Diseases
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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....
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....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01226355
Start Date
April 1 2009
End Date
November 1 2014
Last Update
May 22 2012
Active Locations (1)
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1
Fuwai Hospital, National Center for Cardiovascular Diseases
Beijing, China, 100037