Coronary Artery DiseasePhase 2/3SERY-INCT01373645
Safety and Efficacy Registry of Yinyi Stent
A Phase 2/3 study testing Yinyi stent in people with Coronary Artery Disease, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Drug-eluting stents effectively reduce restenosis but may increase late thrombosis and delayed restenosis. Persistent polymer could be responsible. Local delivery of paclitxel from a polymer-free Yinyi stent (Dalian Yinyi biomaterial research and development co.ltd) may prevent these complications. 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?
- Yinyi stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,045 participants
- Where
- 1 siteChina
- Study dates
- Jan 2009to Dec 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 > 70%
- vessel size 2.5-4.0 in diameter
Who cannot join
- without informed consent,
- ST elevation myocardial infarction within 7 days,
- patient with ≤ 70% coronary narrowing at target lesion,
- left main lesion,
- multivessel narrowing need more than 3 stent implantations,
- by-pass graft,
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- abnormal liver function before randomization,
- 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
ruijin hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: Safety and Efficacy Registry of Yinyi Polymer-free Paclitaxel-eluting Stent
Drug-eluting stents effectively reduce restenosis but may increase late thrombosis and delayed restenosis. Persistent polymer could be responsible. Local delivery of paclitxel from a polymer-free Yinyi stent (Dalian Yinyi biomaterial research and development co.ltd) may prevent these complications.
- Conditions
- Coronary Artery Disease
- Being tested
- Yinyi 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.
Yinyi stentDevice
subjects with Yinyi stent implantation
| Study group | Role | What they receive |
|---|---|---|
| Yinyi stent | Experimental | subjects with Yinyi stent implantation Receives: Device: Yinyi stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cardiac events
including cardiac death, myocardial infarction and target vessel failure
Measured: 12 months
Secondary outcomes (1)
stent thrombosis
according to ARC definition
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 posted15 Jun 2011 (estimated)
- Study startJan 2009
- Primary completionDec 2011
- Study completionDec 2011
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 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,045 participants (actual)
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
- NCT01373645
- Sponsor's protocol ID
- RJH20100909
- Acronym
- SERY-I
- Status last verified
- Oct 2008
- First submitted
- 1 Apr 2011
- Last updated
- 29 Jul 2015
- Results posted
- No
Publications
Zhang RY, Zhang Q, Zhu JZ, Chen LL, Zhang CY, Zhou XC, Yuan Y, Zhong ZX, Li L, Qiu J, Wang W, Chen XM, Yang ZJ, Yan JC, Chen SL, Hou YQ, Wu YQ, Luo HM, Qiu JP, Zhu L, Wang Y, Fu GS, Wang JA, Ma KH, Yin YH, Zhang DF, Hu XS, Zhu GY, Shen WF; Safety and Efficacy Registry of Yinyi stent (SERY-I) Investigators. Safety and efficacy of polymer-free paclitaxel-eluting microporous stent in real-world practice: 1-year follow-up of the SERY-I registry. Chin Med J (Engl). 2011 Nov;124(21):3521-6. No abstract available.
PubMed 22340171
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Registry of Yinyi Polymer-free Paclitaxel-eluting Stent
- ClinicalTrials.gov ID
- NCT01373645
- Acronym / sponsor ID
- SERY-I / RJH20100909
- Conditions
- Coronary Artery Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,045 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- 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.
Drug-eluting stents effectively reduce restenosis but may increase late thrombosis and delayed restenosis. Persistent polymer could be responsible. Local delivery of paclitxel from a polymer-free Yinyi stent (Dalian Yinyi biomaterial research and development co.ltd) may prevent these complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yinyi stent | Experimental | Device: Yinyi stentsubjects with Yinyi stent implantation |
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 > 70%
- vessel size 2.5-4.0 in diameter
Key exclusion criteria (11 listed)
- without informed consent,
- ST elevation myocardial infarction within 7 days,
- patient with ≤ 70% coronary narrowing at target lesion,
- left main lesion,
- multivessel narrowing need more than 3 stent implantations,
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 |
|---|---|---|
| Yinyi stentsubjects with Yinyi stent implantation | Device | Yinyi stent |
Primary outcome
major adverse cardiac events
Time frame: 12 months
including cardiac death, myocardial infarction and target vessel failure
1 secondary outcome
stent thrombosis
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
- Results publication: PubMed 22340171Zhang RY, Zhang Q, Zhu JZ, Chen LL, Zhang CY, Zhou XC, Yuan Y, Zhong ZX, Li L, Qiu J, Wang W, Chen XM, Yang ZJ, Yan JC, Chen SL, Hou YQ, Wu YQ, Luo HM, Qiu JP, Zhu L, Wang Y, Fu GS, Wang JA, Ma KH, Yin YH, Zhang DF, Hu XS, Zhu GY, Shen WF; Safety and Efficacy Registry of Yinyi stent (SERY-I) Investigators. Safety and efficacy of polymer-free paclitaxel-eluting microporous stent in real-world practice: 1-year follow-up of the SERY-I registry. Chin Med J (Engl). 2011 Nov;124(21):3521-6. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Yinyi 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 11 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: finished, as of the sponsor's last update on 29 Jul 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 NCT01373645, 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 29 Jul 2015.