Firebird2 Cobalt-Chromium Alloyed Sirolimus-Eluting Stent Registry Trial
FOCUS
1 other identifier
interventional
5,000
1 country
1
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-ChromiumAlloyed Sirolimus-Eluting Stent implantation. For patient with multivessel disease, only Firebird 2TM Stent will be implanted. The enrollment of patients will take about 4 months. Clinical follow-up will be at 30 day, 6 month, 12 month, 24 month and 36 month. Patients withdrawing the study due to any reasons will not be replaced.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2009
CompletedFirst Posted
Study publicly available on registry
March 25, 2009
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedAugust 10, 2011
August 1, 2011
3.9 years
March 23, 2009
August 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
rate of major adverse cardiac events
12 months
Study Arms (1)
Firebird2
EXPERIMENTALInterventions
For the patient participated, only Firebird2 Stent will be implanted.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Related Publications (1)
Zhang F, Yang J, Qian J, Ge L, Zhou J, Ge J; FOCUS registry investigators. Long-term performance of the second-generation cobalt-chromium sirolimus-eluting stents in real-world clinical practice: 3-year clinical outcomes from the prospective multicenter FOCUS registry. J Thorac Dis. 2016 Jul;8(7):1601-10. doi: 10.21037/jtd.2016.05.11.
PMID: 27499948DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Junbo Ge
Shanghai Zhongshan Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 23, 2009
First Posted
March 25, 2009
Study Start
April 1, 2009
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
August 10, 2011
Record last verified: 2011-08