Coronary Artery DiseasePhase 4FESTANCT01373632
Firebird 2 Versus Excel Sirolimus-eluting Stent in Treating Real-world Patients With Coronary Artery Disease
A Phase 4 study testing Firebird 2 sirolimus-eluting stent and Excel sirolimus-eluting stent in people with Coronary Artery Disease, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Sirolimus-eluting stent (SES) has been world-widely used in clinical practice in treating patients with coronary artery disease (CAD). The efficacy and safety of Excel SES (JW Medical, Shandong, China, MA) with biodegradable polymer has been proved by several clinical trials. 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 sirolimus-eluting stent and Excel sirolimus-eluting stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 570 participants
- Where
- 1 siteChina
- Study dates
- Jun 2011to Sep 2013
- Phase
- Phase 4
- 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
- male or un-pregnant female
- stenosis > 70% in one of major the epicardial coronary arteries
- no contra-indications of stent implantation
- singed the informed consent
Who cannot join
- acute myocardial infarction within one week
- have contra-indications of stent implantation or can not tolerate dual antiplatelet therapy
- no history of stent implantation within last one-year
- received other brand coronary stent during index procedure
- with no achievement of informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
WeiFeng Shen, MD, PhD, 86-21-64370045 ext. 665215, rjshenweifeng@yahoo.com.cn
Xian Zhang, MD, 86-21-64370045 ext. 665215
About this study
Official title: Multicenter, Randomized, Non-inferiority Study of Firebird 2 Versus Excel Sirolimus-eluting Stent in Treating Real-world Patients With Coronary Artery Disease
Sirolimus-eluting stent (SES) has been world-widely used in clinical practice in treating patients with coronary artery disease (CAD). The efficacy and safety of Excel SES (JW Medical, Shandong, China, MA) with biodegradable polymer has been proved by several clinical trials. Here the investigators design a prospective, multicenter, randomized clinical study in purpose of identifying the non-inferiority in the efficacy and safety in treating CAD patients by Firebird 2 SES (Microport, Shanghai) with durable polymer, comparing with Excel SES.
- Conditions
- Coronary Artery Disease
- Being tested
- Firebird 2 sirolimus-eluting stent, Excel sirolimus-eluting stent
- Keywords
- significant stenosis (>70% of lumen stenosis), epicardial coronary arteries, clinical ischemic
- 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 sirolimus-eluting stentDevice
the Firebird 2 sirolimus-eluting stent is a SES with durable polymer based on Co-Cr stent platform
Excel sirolimus-eluting stentDevice
the Excel sirolimus-eluting stent is a stent with biodegradable polymer (PLA) based on stainless steel (316L) stent platform
| Study group | Role | What they receive |
|---|---|---|
| Firebird 2 stent group | Experimental | the patients who receive Firebird 2 stent Receives: Device: Firebird 2 sirolimus-eluting stent |
| Excel stent group | Active comparator | the patients who receive Excel stent Receives: Device: Excel sirolimus-eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
in-stent late lumen loss at 9 months' angiographic follow-up
patients are planned to receive angiographic follow-up at 9 months after index procedure, and in-stent late lumen loss will be analyzed
Measured: 9 months
Secondary outcomes (1)
target vessel failure
defined as the occurrence of any of the following within 1 and 2 years after the index procedure: death from cardiac causes, Q-wave or non-Q-wave myocardial infarction, or revascularizationof the target vessel (emergency or elective coronaryartery bypass grafting [CABG] or repeated percutaneous transluminal coronary angioplasty [PTCA]).
Measured: 2 years after index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2012 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373632
- Sponsor's protocol ID
- 20110611
- Acronym
- FESTA
- Status last verified
- Jun 2011
- First submitted
- 13 Jun 2011
- Last updated
- 15 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang Q, Xu B, Yang YJ, Zhang RY, Li JP, Qiao SB, Zhang JS, Hu J, Qin XW, Hong T, Chen JL, Huo Y, Shen WF, Gao RL. Sirolimus-eluting cobalt alloyed stents in treating patients with coronary artery disease: six-month angiographic and one-year clinical follow-up result. A prospective, historically controlled, multi-center clinical study. Chin Med J (Engl). 2007 Apr 5;120(7):533-8.
PubMed 17442198Han Y, Jing Q, Chen X, Wang S, Ma Y, Liu H, Luan B, Wang G, Li Y, Wang Z, Wang D, Xu B, Gao R. Long-term clinical, angiographic, and intravascular ultrasound outcomes of biodegradable polymer-coated sirolimus-eluting stents. Catheter Cardiovasc Interv. 2008 Aug 1;72(2):177-83. doi: 10.1002/ccd.21600.
PubMed 18655114
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Non-inferiority Study of Firebird 2 Versus Excel Sirolimus-eluting Stent in Treating Real-world Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01373632
- Acronym / sponsor ID
- FESTA / 20110611
- Conditions
- Coronary Artery Disease
- Keywords
- significant stenosis (>70% of lumen stenosis), epicardial coronary arteries, clinical ischemic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 15 Jun 2011 (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.
Sirolimus-eluting stent (SES) has been world-widely used in clinical practice in treating patients with coronary artery disease (CAD). The efficacy and safety of Excel SES (JW Medical, Shandong, China, MA) with biodegradable polymer has been proved by several clinical trials. Here the investigators design a prospective, multicenter, randomized clinical study in purpose of identifying the non-inferiority in the efficacy and safety in treating CAD patients by Firebird 2 SES (Microport, Shanghai) with durable polymer, comparing with Excel SES.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Firebird 2 stent group | Experimental | Device: Firebird 2 sirolimus-eluting stentthe patients who receive Firebird 2 stent |
| Excel stent group | Active comparator | Device: Excel sirolimus-eluting stentthe patients who receive Excel stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age > 18 years
- male or un-pregnant female
- stenosis > 70% in one of major the epicardial coronary arteries
- no contra-indications of stent implantation
- singed the informed consent
Key exclusion criteria (5 listed)
- acute myocardial infarction within one week
- have contra-indications of stent implantation or can not tolerate dual antiplatelet therapy
- no history of stent implantation within last one-year
- received other brand coronary stent during index procedure
- with no achievement of informed consent
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 sirolimus-eluting stentthe Firebird 2 sirolimus-eluting stent is a SES with durable polymer based on Co-Cr stent platform | Device | Firebird 2 stent group |
| Excel sirolimus-eluting stentthe Excel sirolimus-eluting stent is a stent with biodegradable polymer (PLA) based on stainless steel (316L) stent platform | Device | Excel stent group |
Primary outcome
in-stent late lumen loss at 9 months' angiographic follow-up
Time frame: 9 months
patients are planned to receive angiographic follow-up at 9 months after index procedure, and in-stent late lumen loss will be analyzed
1 secondary outcome
target vessel failure
Time frame: 2 years after index procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2011.
- Background: PubMed 17442198Zhang Q, Xu B, Yang YJ, Zhang RY, Li JP, Qiao SB, Zhang JS, Hu J, Qin XW, Hong T, Chen JL, Huo Y, Shen WF, Gao RL. Sirolimus-eluting cobalt alloyed stents in treating patients with coronary artery disease: six-month angiographic and one-year clinical follow-up result. A prospective, historically controlled, multi-center clinical study. Chin Med J (Engl). 2007 Apr 5;120(7):533-8.
- Background: PubMed 18655114Han Y, Jing Q, Chen X, Wang S, Ma Y, Liu H, Luan B, Wang G, Li Y, Wang Z, Wang D, Xu B, Gao R. Long-term clinical, angiographic, and intravascular ultrasound outcomes of biodegradable polymer-coated sirolimus-eluting stents. Catheter Cardiovasc Interv. 2008 Aug 1;72(2):177-83. doi: 10.1002/ccd.21600.
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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.
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Firebird 2 sirolimus-eluting stent and Excel sirolimus-eluting stent in people with Coronary Artery Disease, run by Shanghai Jiao Tong University School of Medicine 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 5 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 15 Jun 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
in-stent late lumen loss at 9 months' angiographic follow-up (time frame: 9 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 NCT01373632, which also lists 2 linked publications.
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 15 Jun 2011.