Status:
UNKNOWN
Firebird2 Cobalt-Chromium Alloyed Sirolimus-Eluting Stent Registry Trial
Lead Sponsor:
Shanghai MicroPort Medical (Group) Co., Ltd.
Conditions:
Coronary Heart Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The experimental design is a multi-center, prospective, non-controlled, non-randomized, single-arm clinical registry trial. The study will enroll 5,000 patients who receive the Firebird2TM Cobalt-Chro...
Detailed Description
\[Definition and management of adverse event\] Adverse event refers to any undesirable clinical event. It may be caused by devices, rapamycin, procedure related complications, or the adjunctive medica...
Eligibility Criteria
Inclusion
- Age≧18 years
- Patient being suitable candidate for the implantation of drug-eluting stent at physician's discretion
- Patient with multivessel disease who receive only Firebird2 Stent
- Patient agrees to provide informed consent to follow the clinical trial protocol, including medications, and baseline and follow-up visits and procedures.
Exclusion
- Patient not being suitable candidate for the implantation of drug-eluting stent at physician's discretion
- Patient with multivessel disease who receive other type of stents instead of only Firebird2 Stent
- Patient who receive other PCI interventions, such as rotablation, directional coronary atherectomy (DCA), TEC, CRA, laser angioplasty, etc.), in addition to PTCA and stenting
- Patient refuses to provide informed consent
- Patient who are not able to follow the clinical trial protocol, including medications, and baseline and follow-up visits and procedures
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2013
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT00868829
Start Date
April 1 2009
End Date
March 1 2013
Last Update
August 10 2011
Active Locations (1)
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1
Zhongshan Hospital
Shanghai, Shanghai Municipality, China