Angina, UnstablePhase 4NCT02868203
OCT Based Edge and In-stent Vascular Response After Cordimax Stent in patIents With NSTE-ACS
A Phase 4 study testing OCT and eLuting stent in people with Angina, Unstable and Non-ST-Segment Elevation Myocardial Infarction, run by Xijing Hospital.
Trial summary
This study evaluates the completeness of strut coverage and vessel wall response, at different time points (3-6-12 Months), following CordimaxTM stent implantation in patients with non-ST elevation acute coronary syndrome Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Angina, Unstable, Non-ST-Segment Elevation Myocardial Infarction
- What is being tested?
- OCT and eLuting stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Aug 2020
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥18 and ≤ 75 years
- Non-ST-segment elevation MI
- Patient willing to comply with specified follow-up
- 5.Patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent 6.Single or two de novo or non-stented restenotic lesion in a native coronary artery 7. Target lesion to be covered by a single stent of max 30 mm . Reference vessel diameter ≥2.25 to ≤ 4.0 mm by visual estimate 8. The vessel diameter should be measured after pre-dilation procedure and after intra-coronary nitroglycerin if spasm is suspected 9. Target lesion ≥70% stenosed by visual estimate
Who cannot join
- Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of childbearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test
- Impaired renal function or on dialysis
- Platelet count <100,000 cells/mm3 or >700,000 cells/mm3 or a WBC<3,000 cells/mm3
- Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated
- Patient requires low molecular weight heparin (LMWH) treatment postprocedure or has received a dose of LMWH ≤8 hours prior to index procedure
- Patient has received any organ transplant or is on a waiting list for any organ transplant;
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- Patient has other medical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (<1 year)
- Patient has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, prasugrel, stainless steel alloy, sirolimus and/or contrast sensitivity that cannot be adequately pre-medicated
- Patient has previously received murine therapeutic antibodies and exhibited sensitization through the production of Human Anti-Murine Antibodies
- Patient presents with cardiogenic shock
- Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion;
- Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study
- Currently participating in another investigational drug or device study or patient in inclusion in another investigational drug or device study during follow-up
- Calcified target lesion(s) which cannot be successfully predilated
- Target lesion has excessive tortuosity unsuitable for stent delivery and deployment;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Optical Coherence tOmography Based Edge and In-stent Vascular Response After a Novel bioDegradable Polymer sIrolimus-eLuting Stent in patIents With Non-ST Elevation acuTe Coronary sYndrome (NSTE ACS)
This study evaluates the completeness of strut coverage and vessel wall response, at different time points (3-6-12 Months), following CordimaxTM stent implantation in patients with non-ST elevation acute coronary syndrome
Read the detailed description
Major concerns were addressed to the delayed healing process of drug-eluting stents . To date no studies have detailed the in-vivo completeness of CordimaxTM stent coverage at different time points. The objective of this prospective study is to measure the completeness of strut coverage and vessel wall response (neointima disomogeneity, acquired late incomplete strut apposition) at different time points following CordimaxTM stent implantation, in patients with non-ST elevation acute coronary syndrome . Optical Coherence Tomography (OCT) that detects smaller degrees of stent strut coverage more accurately than IVUS will be used at different time points (3-6-12 Months)
- Being tested
- OCT, eLuting stent
- Medical subject headings
- Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCTDevice
OCT after stent implantation
eLuting stentDevice
| Study group | Role | What they receive |
|---|---|---|
| OCT at 3 months | Active comparator | OCT at 3 months and 12 OCT at 3 months Receives: Device: OCT; Device: eLuting stent |
| OCT at 6months | Active comparator | OCT at 6 months and 12 OCT at 3 months Receives: Device: OCT; Device: eLuting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of uncovered and/or malapposed bioDegradable polymer sIrolimus-eLuting stent at 12 month after the implant, as measured by OCT
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2018 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina, UnstableStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868203
- Sponsor's protocol ID
- ky20162025-1
- Status last verified
- May 2016
- First submitted
- 11 Aug 2016
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence tOmography Based Edge and In-stent Vascular Response After a Novel bioDegradable Polymer sIrolimus-eLuting Stent in patIents With Non-ST Elevation acuTe Coronary sYndrome (NSTE ACS)
- ClinicalTrials.gov ID
- NCT02868203
- Acronym / sponsor ID
- ky20162025-1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 16 Aug 2016 (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.
This study evaluates the completeness of strut coverage and vessel wall response, at different time points (3-6-12 Months), following CordimaxTM stent implantation in patients with non-ST elevation acute coronary syndrome
Detailed description
Major concerns were addressed to the delayed healing process of drug-eluting stents . To date no studies have detailed the in-vivo completeness of CordimaxTM stent coverage at different time points. The objective of this prospective study is to measure the completeness of strut coverage and vessel wall response (neointima disomogeneity, acquired late incomplete strut apposition) at different time points following CordimaxTM stent implantation, in patients with non-ST elevation acute coronary syndrome . Optical Coherence Tomography (OCT) that detects smaller degrees of stent strut coverage more accurately than IVUS will be used at different time points (3-6-12 Months)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCT at 3 months | Active comparator | Device: OCT, Device: eLuting stentOCT at 3 months and 12 OCT at 3 months |
| OCT at 6months | Active comparator | Device: OCT, Device: eLuting stentOCT at 6 months and 12 OCT at 3 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age ≥18 and ≤ 75 years
- Non-ST-segment elevation MI
- Patient willing to comply with specified follow-up
- 5.Patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent 6.Single or two de novo or non-stented restenotic lesion in a native coronary artery 7. Target lesion to be covered by a single stent of max 30 mm . Reference vessel diameter ≥2.25 to ≤ 4.0 mm by visual estimate 8. The vessel diameter should be measured after pre-dilation procedure and after intra-coronary nitroglycerin if spasm is suspected 9. Target lesion ≥70% stenosed by visual estimate
Key exclusion criteria (15 listed)
- Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of childbearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test
- Impaired renal function or on dialysis
- Platelet count <100,000 cells/mm3 or >700,000 cells/mm3 or a WBC<3,000 cells/mm3
- Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated
- Patient requires low molecular weight heparin (LMWH) treatment postprocedure or has received a dose of LMWH ≤8 hours prior to index procedure
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 |
|---|---|---|
| OCTOCT after stent implantation | Device | OCT at 3 months, OCT at 6months |
| eLuting stent | Device | OCT at 3 months, OCT at 6months |
Primary outcome
Proportion of uncovered and/or malapposed bioDegradable polymer sIrolimus-eLuting stent at 12 month after the implant, as measured by OCT
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OCT and eLuting stent in people with Angina, Unstable and Non-ST-Segment Elevation Myocardial Infarction, run by Xijing Hospital.
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 15 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 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact ling tao, doctor (86-29-84775183, lingtao@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of uncovered and/or malapposed bioDegradable polymer sIrolimus-eLuting stent at 12 month after the implant, as measured by OCT (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 16 Aug 2016.