Coronary Artery DiseasePhase 2/3SESILNCT01375296
China Made Sirolimus Eluting Stent for Intermediate Lesion
A Phase 2/3 study testing China-made SES (Firebird 2 and Excel) and routine medicine 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 proven to improve outcomes in patients with significant coronary artery diseae(> 70% lumen diameter narrowing). But, acute coronary syndrome may occur in those with intermediate lesions(50%-70% lumen diameter narrowing), and the effect of SES in these patients remains unclear. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- China-made SES (Firebird 2 and Excel) and routine medicine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- May 2009to Nov 2011
- Phase
- Phase 2/3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-80 years old
- both gender
- native coronary lesion
- narrowing 50-70%
- vessel size 2.5-4.0 in diameter
Who cannot join
- without informed consent,
- ST elevation myocardial infarction within 7 days,
- left main lesion,
- by-pass graft,
- restenosis
- abnormal liver function before randomization,
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- active hepatitis or muscular disease,
- impaired renal function with serum creatinine level > 3mg/dl ,
- impaired left ventricular function with LVEF < 30%,
- participate in other studies.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
ruijin hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, Shanghai Municipality, 200025
Ruiyan Zhang, MD, 862164370045 ext. 665215, zhangruiyan@263.net
About this study
Official title: China Made Sirolimus Eluting Stent for Treatment of Coronary Intermediate Lesion
Sirolimus-eluting stent (SES) has been proven to improve outcomes in patients with significant coronary artery diseae(> 70% lumen diameter narrowing). But, acute coronary syndrome may occur in those with intermediate lesions(50%-70% lumen diameter narrowing), and the effect of SES in these patients remains unclear. Here the investigators hypothesize that application of China-made SES may improve the clinical outcomes in these setting.
- Conditions
- Coronary Artery Disease
- Being tested
- China-made SES (Firebird 2 and Excel), routine medicine
- 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.
China-made SES (Firebird 2 and Excel)Device
patients with coronary 50-70% narrowing treated with China-made SES stent,i.e. Firebird 2 (cobalt-alloy platform with durable polymer coating sirolimus-eluting stent) and Excel (stainless steel platform with biodegradable polymer coating sirolimus-eluting stent).
routine medicineOther
patients with coronary 50-70% narrowing treated with routine medicine
| Study group | Role | What they receive |
|---|---|---|
| SES | Experimental | including two types of China-made SES, i.e. Firebird 2 (cobalt-alloy platform with durable polymer coating sirolimus-eluting stent) and Excel (stainless steel platform with biodegradable polymer coating sirolimus-eluting stent). Receives: Device: China-made SES (Firebird 2 and Excel) |
| medicine | Other | Not described Receives: Other: routine medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
target vessel failure
defined as the occurrence of any of the following within 12 months after the index procedure: death from cardiac causes, Q-wave or non-Q-wave myocardial infarction, or revascularization of the target vessel (emergency or elective coronaryartery bypass grafting [CABG] or repeated percutaneous transluminal coronary angioplasty [PTCA]).
Measured: 12 months
Secondary outcomes (1)
major adverse cardiac events
including cardiac death, re-infarction and target vessel revascularization.
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 posted17 Jun 2011 (estimated)
- Study startMay 2009
- Primary completionOct 2011 (estimated)
- Study completionNov 2011 (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 Shanghai Jiao Tong University School of MedicineThe 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 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
- NCT01375296
- Sponsor's protocol ID
- RJH20100918
- Acronym
- SESIL
- Status last verified
- Apr 2009
- First submitted
- 1 Apr 2011
- Last updated
- 17 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Made Sirolimus Eluting Stent for Treatment of Coronary Intermediate Lesion
- ClinicalTrials.gov ID
- NCT01375296
- Acronym / sponsor ID
- SESIL / RJH20100918
- Conditions
- Coronary Artery Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 17 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 proven to improve outcomes in patients with significant coronary artery diseae(> 70% lumen diameter narrowing). But, acute coronary syndrome may occur in those with intermediate lesions(50%-70% lumen diameter narrowing), and the effect of SES in these patients remains unclear. Here the investigators hypothesize that application of China-made SES may improve the clinical outcomes in these setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SES | Experimental | Device: China-made SES (Firebird 2 and Excel)including two types of China-made SES, i.e. Firebird 2 (cobalt-alloy platform with durable polymer coating sirolimus-eluting stent) and Excel (stainless steel platform with biodegradable polymer coating sirolimus-eluting stent). |
| medicine | Other | Other: routine medicine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 18-80 years old
- both gender
- native coronary lesion
- narrowing 50-70%
- vessel size 2.5-4.0 in diameter
Key exclusion criteria (10 listed)
- without informed consent,
- ST elevation myocardial infarction within 7 days,
- left main lesion,
- by-pass graft,
- restenosis
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 |
|---|---|---|
| China-made SES (Firebird 2 and Excel)patients with coronary 50-70% narrowing treated with China-made SES stent,i.e. Firebird 2 (cobalt-alloy platform with durable polymer coating sirolimus-eluting stent) and Excel (stainless steel platform with biodegradable polymer coating sirolimus-eluting stent). | Device | SES |
| routine medicinepatients with coronary 50-70% narrowing treated with routine medicine | Other | medicine |
Primary outcome
target vessel failure
Time frame: 12 months
defined as the occurrence of any of the following within 12 months after the index procedure: death from cardiac causes, Q-wave or non-Q-wave myocardial infarction, or revascularization of the target vessel (emergency or elective coronaryartery bypass grafting [CABG] or repeated percutaneous transluminal coronary angioplasty [PTCA]).
1 secondary outcome
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 17 Jun 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing China-made SES (Firebird 2 and Excel) and routine medicine 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 10 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 17 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Ruiyan Zhang, MD (862164370045 ext. 665215, zhangruiyan@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
target vessel failure (time frame: 12 months). 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 17 Jun 2011.