Status:
UNKNOWN
ProStent Coronary Drug-Eluting Stent
Lead Sponsor:
CCRF Consulting Co., Ltd.
Conditions:
Coronary Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
A single blind, multi-center, randomized study is preformed to compare ProStent drug-eluting stents with Firebird drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd. to evaluate the safety...
Detailed Description
A single blind, multi-center, randomized study is preformed to compare ProStent drug-eluting stents with Firebird drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd. to evaluate the safety...
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, 2.5 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 fellow-up
Exclusion
- Patients with acute myocardial infarction in recent one month;
- 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 ≥2.5mm;
- 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 :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2010
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT00887211
Start Date
October 1 2008
End Date
March 1 2010
Last Update
April 30 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fuwai Hospital
Beijing, China, 100037