Coronary Heart DiseaseFOCUSNCT00868829
Firebird2 Cobalt-Chromium Alloyed Sirolimus-Eluting Stent Registry Trial
A study testing Firebird2 in people with Coronary Heart Disease, run by Shanghai MicroPort Medical (Group) Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Firebird2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- Apr 2009to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality
Caihong Wang, wch@ccheart.com.cn
About this study
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.
Read the 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 medications (such as aspirin, clopidogrel, ticlopidine, or other anti-platelet agent) used in this study. Self report of adverse events by patients should be encouraged. Patients have a right to inquire any information on adverse event at any time of the study. If an adverse event is confirmed, the investigator should collect all related information and complete the Adverse Event Form.
[Classification of adverse events severity] Mild: Mild adverse event refers to clinical event not interfering patient's daily activities.
Moderate: Moderate adverse event refers to clinical event affecting patient's daily activities.
Serious: Serious adverse event refers to clinical event results in patient's inability to undertake daily activity.
[Management of adverse event] All adverse events occurring during the study period should be documented on Adverse Event Forms. Investigators should provide appropriate treatment for all adverse events and follow up the patient until symptom(s) disappear or remain stable
[Documents Recordkeeping] All CRFs and their other original supporting files (such as the informed consent, the lab report, the process records, medical history, the results of physical examinations and diagnosis, the diagnosis, procedure dates and the records regarding equipment management) must be set up in a secure central location by a research site staff and maintained for at least 2 years upon the notification on the termination or completion of the trial issued by MicroPort Medical.
In case the person in charge of keeping these files cannot keep the trial records continuously due to retirement, transferring or any other reason, the recordkeeping should be handed over to another person who is able to accept this task, and a written notification with the successor's name and address should be sent to MicroPort and the Ethics Committee.
- Conditions
- Coronary Heart Disease
- Being tested
- Firebird2
- Keywords
- Stent, FireBird2, Coronary Heart Disease
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Firebird2Device
Also called Firebird2 Cobalt-Chromium Alloyed Sirolimus-Eluting Stent
For the patient participated, only Firebird2 Stent will be implanted.
| Study group | Role | What they receive |
|---|---|---|
| Firebird2 | Experimental | Not described Receives: Device: Firebird2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of major adverse cardiac events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Junbo Ge, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00868829
- Sponsor's protocol ID
- MPMFB22009
- Acronym
- FOCUS
- Status last verified
- Aug 2011
- First submitted
- 23 Mar 2009
- Last updated
- 10 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27499948
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Firebird2 Cobalt-Chromium Alloyed Sirolimus-Eluting Stent Registry Trial
- ClinicalTrials.gov ID
- NCT00868829
- Acronym / sponsor ID
- FOCUS / MPMFB22009
- Conditions
- Coronary Heart Disease
- Keywords
- Stent, FireBird2, Coronary Heart Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 25 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 medications (such as aspirin, clopidogrel, ticlopidine, or other anti-platelet agent) used in this study. Self report of adverse events by patients should be encouraged. Patients have a right to inquire any information on adverse event at any time of the study. If an adverse event is confirmed, the investigator should collect all related information and complete the Adverse Event Form.
[Classification of adverse events severity] Mild: Mild adverse event refers to clinical event not interfering patient's daily activities.
Moderate: Moderate adverse event refers to clinical event affecting patient's daily activities.
Serious: Serious adverse event refers to clinical event results in patient's inability to undertake daily activity.
[Management of adverse event] All adverse events occurring during the study period should be documented on Adverse Event Forms. Investigators should provide appropriate treatment for all adverse events and follow up the patient until symptom(s) disappear or remain stable
[Documents Recordkeeping] All CRFs and their other original supporting files (such as the informed consent, the lab report, the process records, medical history, the results of physical examinations and diagnosis, the diagnosis, procedure dates and the records regarding equipment management) must be set up in a secure central location by a research site staff and maintained for at least 2 years upon the notification on the termination or completion of the trial issued by MicroPort Medical.
In case the person in charge of keeping these files cannot keep the trial records continuously due to retirement, transferring or any other reason, the recordkeeping should be handed over to another person who is able to accept this task, and a written notification with the successor's name and address should be sent to MicroPort and the Ethics Committee.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Firebird2 | Experimental | Device: Firebird2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Firebird2Also: Firebird2 Cobalt-Chromium Alloyed Sirolimus-Eluting StentFor the patient participated, only Firebird2 Stent will be implanted. | Device | Firebird2 |
Primary outcome
rate of major adverse cardiac events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2011.
- Derived from this study: PubMed 27499948Zhang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junbo Ge principal investigator
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Firebird2 in people with Coronary Heart Disease, run by Shanghai MicroPort Medical (Group) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caihong Wang (68-10-84094918 ext. 838, wch@ccheart.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of major adverse cardiac events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00868829, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2011.