Coronary Artery DiseasePhase 2/3SERY-IINCT01373658
Safety and Efficacy Registry of Yinyi Stent (SERY-II)
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
- 200 participants
- Where
- 1 siteChina
- Study dates
- May 2010to 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, 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: 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 | Not described Receives: Device: Yinyi stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
late lumen loss
Late luminal loss was defined as the difference between the minimal luminal diameter immediately after the placement of the stent and the minimal luminal diameter at 12-month angiographic follow-up.
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 posted15 Jun 2011 (estimated)
- Study startMay 2010
- Primary completionOct 2011 (estimated)
- Study completionDec 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Ruiyan Zhang, MD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373658
- Sponsor's protocol ID
- RJH20100910
- Acronym
- SERY-II
- Status last verified
- Mar 2010
- First submitted
- 1 Apr 2011
- Last updated
- 15 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
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
- Safety and Efficacy Registry of Yinyi Polymer-free Paclitaxel-eluting Stent
- ClinicalTrials.gov ID
- NCT01373658
- Acronym / sponsor ID
- SERY-II / RJH20100910
- Conditions
- Coronary Artery Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Dec 2011 (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.
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 stent |
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
late lumen loss
Time frame: 12 months
Late luminal loss was defined as the difference between the minimal luminal diameter immediately after the placement of the stent and the minimal luminal diameter at 12-month angiographic follow-up.
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 15 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.
Ruiyan Zhang, MD principal investigator
Ruijin Hospital
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: 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 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?
late lumen loss (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 15 Jun 2011.