Coronary Artery DiseaseNCT01257373
Efficacy and Safety of Firebird 2 Stent in Treatment of Complex Coronary Lesions in Diabetes
An observational study of Coronary Artery Disease, run by Xijing Hospital at 1 site in China.
Trial summary
The goal of this study is to assess the long-term efficacy and safety of Firebird2 Cobalt-Chromium（CoCr）-alloyed sirolimus-eluting stent in treatment of complex lesions in diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Firebird 2 Cobalt-Chromium Alloyed Sirolimus-Eluting Stent
- Type of treatment
- Medical device
- How many people
- 1,300 participants
- Where
- 1 siteChina
- Study dates
- Apr 2010to Apr 2013
- Phase
- Observational
- 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
Study population: This registry study will be conducted in 56 centers in which Firebird 2 stent is implemented. The data of 1300 patients, in which only Fireibrd2 stent is implanted, will be collected. All inclusive patients should be definitely diagnosed type 2 DM, either before or during the present hospitalization and with complex coronary lesions. The diagnosis criteria is the World Health Organization(WHO) recommended criteria 1999 version. I.e., fasting blood glucose ≥7.0mmol/L，random blood glucose ≥11.1mmol/L，or OGTT 2h blood glucose ≥11.1mmol/L. Impaired fasting glucose (6.0mmol/L～7.0mmol/L) or Impaired glucose tolerance (oral glucose tolerance test(OGTT) 2h blood glucose 7.8mmol/L～11.1mmol/L) can not be enrolled. The stress-induced hyperglycemia of acute coronary syndrome is illegible.
Who may be able to join
- Definitely diagnosed type 2 DM either before or during the current hospitalization and with complex coronary lesions
- The coronary lesion is complied with the definition of complex type. (defined by protocol)
- The investigator admitted patients which are suitable for implanting Firebird2 CoCr-alloyed Sirolimus-eluting stent(SES)
- Patient or his/ her legal supervisor are provided with informed consents.
Who cannot join
- Women during pregnancy and breast-feeding;
- ST-segment elevated MI occurred within 1 week;
- Graft lesion after the coronary artery bypass graft(CABG) operation;
- Patient with other brand of stent implanted;
- LVEF ≤ 35%;
- Renal insufficiency before operation (Serum creatinine ≥ 177umol/L)
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- Impaired fasting glucose（6.0mmol/L～7.0mmol/L）or impaired glucose tolerance（OGTT 2h blood glucose 7.8mmol/L～11.1mmol/L）patient;
- Recent PCI within 6 months or previous intravascular radiotherapy;
- Predicted life span is less than 12 months;
- Patient allergic to the following materials: aspirin, heparin, Clopidogrel, CoCr alloy, contrast agent or sirolimus.
- Recent participation of trial medication or other device study without endpoints completion or it is clinically interfering FIRE2-DIABETES study endpoints.
- Considered by other investigators unsuitable for implanting Firebird2 CoCr-alloyed SES
- Patients could not obey the study rules, such as not understanding the study manner, scope or its outcome, not cooperative, not providing the informed consent, not accepting follow-up, not finishing the whole study procedure.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of cardiology of Xijing Hospital, Fourth Military Medical University
Xi'an, Shannxi, 710032
Haichang Wang, MD,PhD, 86-2984775183, wanghc@fmmu.edu.cn
Haichang Wang, MD,PhD
About this study
Official title: Efficacy and Safety of Firebird 2 Cobalt-Chromium Alloyed Sirolimus-Eluting Stent in Treatment of Complex Coronary Lesions in Diabetes
The goal of this study is to assess the long-term efficacy and safety of Firebird2 Cobalt-Chromium（CoCr）-alloyed sirolimus-eluting stent in treatment of complex lesions in diabetes.
Read the detailed description
This clinical trial is an international multi-center prospective clinical registry research, for evaluating the efficacy and safety of Firebird 2 cobalt-chromium alloyed sirolimus-eluting stent in treatment of complex coronary lesions in diabetes. As planned, about 57 research centers all over China, Latin America and Asia-Pacific areas will be involved and, 1300 patients will be enrolled into this research. The implanted stents must all be Firebird2 cobalt-chromium alloyed sirolimus-eluting stent. The patient enrollment will last for 12 months. Clinical follow-up will be done respectively for 30 days, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months. All quitted patients during the study will not be replaced with any substitutes, but categorized in the enrollment failure column. The researcher must state clear the reason of nonenrollment.
- Conditions
- Coronary Artery Disease
- Being tested
- Firebird 2 Cobalt-Chromium Alloyed Sirolimus-Eluting Stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Firebird 2 Cobalt-Chromium Alloyed Sirolimus-Eluting StentDevice
Firebird2 CoCr-alloyed sirolimus-eluting stent system is the 2nd generation of drug-eluting stent(DES). It was registered successfully on Jan. 16, 2009 in China. This stent is based with a CoCr alloyed metal platform. The length is from 13-33mm, the diameter is from 2.5mm-4.0mm.
| Study group | Role | What they receive |
|---|---|---|
| patiens with Firebird 2 stent | The group of 1300 patients, in which only Fireibrd2 stent is implanted, will be collected. All inclusive patients should be definitely diagnosed type 2 diabetic mellitus （DM）, either before or during the present hospitalization and with complex coronary lesion. Receives: Device: Firebird 2 Cobalt-Chromium Alloyed Sirolimus-Eluting Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative major adverse cardiovascular events（MACE）
including cardiac death, Q-wave or Non-Q-wave MI,ischemia driven Target Lesion Revascularization (TLR)
Measured: 12-month
Secondary outcomes (4)
Post-procedure MACE
Measured: 30 days, 6/12/18/24/30/36 months.
Cumulative stent thrombosis
By Academic Research Consortium（ARC） definition (definite and probable)
Measured: 12 months
Ischemia-driven target vessel revascularization(TVR)
The repeated intervention therapy or surgical bypass grafting to any segment of the target vessel is called target vessel revascularization. Target vessel means the entire major coronary arteries proximal or distal to the target lesion, including all upstream and downstream branches and the lesion itself
Measured: 12 months
Stroke
including Ischemic and hemorrhagic stroke
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 posted9 Dec 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2011 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Air Force Military Medical University, China, Chinese Academy of Medical Sciences, Fuwai Hospital, Shanghai MicroPort Medical (Group) Co., Ltd., CCheart Consulting Co., Ltd.
- Investigators
- Haichang Wang, MD，PhD, Principal investigator, Department of cardiology of Xijing Hospital, Fourth Military Medcical Univercsity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257373
- Sponsor's protocol ID
- XJ-2010-01
- Status last verified
- Nov 2009
- First submitted
- 2 Dec 2010
- Last updated
- 30 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Firebird 2 Cobalt-Chromium Alloyed Sirolimus-Eluting Stent in Treatment of Complex Coronary Lesions in Diabetes
- ClinicalTrials.gov ID
- NCT01257373
- Acronym / sponsor ID
- XJ-2010-01
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Air Force Military Medical University, China, Chinese Academy of Medical Sciences, Fuwai Hospital, Shanghai MicroPort Medical (Group) Co., Ltd., CCheart Consulting Co., Ltd.
- Study start
- Apr 2010
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 9 Dec 2010 (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 goal of this study is to assess the long-term efficacy and safety of Firebird2 Cobalt-Chromium（CoCr）-alloyed sirolimus-eluting stent in treatment of complex lesions in diabetes.
Detailed description
This clinical trial is an international multi-center prospective clinical registry research, for evaluating the efficacy and safety of Firebird 2 cobalt-chromium alloyed sirolimus-eluting stent in treatment of complex coronary lesions in diabetes. As planned, about 57 research centers all over China, Latin America and Asia-Pacific areas will be involved and, 1300 patients will be enrolled into this research. The implanted stents must all be Firebird2 cobalt-chromium alloyed sirolimus-eluting stent. The patient enrollment will last for 12 months. Clinical follow-up will be done respectively for 30 days, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months. All quitted patients during the study will not be replaced with any substitutes, but categorized in the enrollment failure column. The researcher must state clear the reason of nonenrollment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patiens with Firebird 2 stent | – | Device: Firebird 2 Cobalt-Chromium Alloyed Sirolimus-Eluting StentThe group of 1300 patients, in which only Fireibrd2 stent is implanted, will be collected. All inclusive patients should be definitely diagnosed type 2 diabetic mellitus （DM）, either before or during the present hospitalization and with complex coronary lesion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This registry study will be conducted in 56 centers in which Firebird 2 stent is implemented. The data of 1300 patients, in which only Fireibrd2 stent is implanted, will be collected. All inclusive patients should be definitely diagnosed type 2 DM, either before or during the present hospitalization and with complex coronary lesions. The diagnosis criteria is the World Health Organization(WHO) recommended criteria 1999 version. I.e., fasting blood glucose ≥7.0mmol/L，random blood glucose ≥11.1mmol/L，or OGTT 2h blood glucose ≥11.1mmol/L. Impaired fasting glucose (6.0mmol/L～7.0mmol/L) or Impaired glucose tolerance (oral glucose tolerance test(OGTT) 2h blood glucose 7.8mmol/L～11.1mmol/L) can not be enrolled. The stress-induced hyperglycemia of acute coronary syndrome is illegible.
Key inclusion criteria (4 listed)
- Definitely diagnosed type 2 DM either before or during the current hospitalization and with complex coronary lesions
- The coronary lesion is complied with the definition of complex type. (defined by protocol)
- The investigator admitted patients which are suitable for implanting Firebird2 CoCr-alloyed Sirolimus-eluting stent(SES)
- Patient or his/ her legal supervisor are provided with informed consents.
Key exclusion criteria (13 listed)
- Women during pregnancy and breast-feeding;
- ST-segment elevated MI occurred within 1 week;
- Graft lesion after the coronary artery bypass graft(CABG) operation;
- Patient with other brand of stent implanted;
- LVEF ≤ 35%;
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 |
|---|---|---|
| Firebird 2 Cobalt-Chromium Alloyed Sirolimus-Eluting StentFirebird2 CoCr-alloyed sirolimus-eluting stent system is the 2nd generation of drug-eluting stent(DES). It was registered successfully on Jan. 16, 2009 in China. This stent is based with a CoCr alloyed metal platform. The length is from 13-33mm, the diameter is from 2.5mm-4.0mm. | Device | patiens with Firebird 2 stent |
Primary outcome
Cumulative major adverse cardiovascular events（MACE）
Time frame: 12-month
including cardiac death, Q-wave or Non-Q-wave MI,ischemia driven Target Lesion Revascularization (TLR)
4 secondary outcomes
Post-procedure MACE
Time frame: 30 days, 6/12/18/24/30/36 months.
Cumulative stent thrombosis
Time frame: 12 months
Ischemia-driven target vessel revascularization(TVR)
Time frame: 12 months
Stroke
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 30 Dec 2010.
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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.
Haichang Wang, MD，PhD principal investigator
Department of cardiology of Xijing Hospital, Fourth Military Medcical Univercsity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Xijing Hospital 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 13 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 30 Dec 2010. 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 Haichang Wang, MD,PhD (86-2984775183, wanghc@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative major adverse cardiovascular events（MACE） (time frame: 12-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2010.