Acute Myocardial InfarctionNeoCoverNCT01875835
Evaluation of Neointimal Coverage of EES and BMS After Implantation in STEMI Patients by Optical Coherence Tomography
A study testing Xience™ V stent (Abbott Vascular, Santa Clara, California, USA) and Multilink-Vision stent(Abbott Vascular, Santa Clara, California, USA) in people with Acute Myocardial Infarction, run by Harbin Medical University at 1 site in China.
Trial summary
Primary percutaneous coronary intervention (PCI) represents the preferred reperfusion strategy for patients with ST-segment elevation myocardial infarction (STEMI), since it is more effective than thrombolytic regimens in reducing adverse events, including death. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Xience™ V stent (Abbott Vascular, Santa Clara, California, USA) and Multilink-Vision stent(Abbott Vascular, Santa Clara, California, USA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Feb 2016
- Phase
- Interventional
- 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: 18-75 years
- Acute MI with ST-segment elevation, within 12 hours from symptoms onset.
- Length of culprit lesion≤25mm.
- Vessel size in between 2.5 and 4.0 mm.
- Signed patient informed consent.
Who cannot join
- Prior administration of thrombolytic therapy.
- Cardiogenic shock.
- Renal failure (Crea≥2.0mg/dL).
- Recent major bleeding.
- Allergy to heparin, aspirin, clopidogrel, everolimus, the polymer components of the Xience V stent, stainless steel, or contrast media.
- Left main disease
Show all 10Show fewer
- Multi-vessel lesion
- Other hemodynamically significant lesion(s) is present in the infarct vessel (or side branches)
- Angiography demonstrates the infarct lesion to be at the site of a previously implanted stent or in bypass grafts.
- No suitable anatomy for OCT scan.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150081
About this study
Official title: Evaluation of Neointimal Coverage of Everolimus-Eluting Stent and Bare-metal Stent After Implantation in STEMI Patients by Optical Coherence Tomography
Primary percutaneous coronary intervention (PCI) represents the preferred reperfusion strategy for patients with ST-segment elevation myocardial infarction (STEMI), since it is more effective than thrombolytic regimens in reducing adverse events, including death. Drug-eluting stents (DES) are currently being widely used in patients with STEMI. The effectiveness of DES to reduce restenosis and the need for revascularization compared with bare-metal stents (BMS) has been documented in randomized controlled trials. The first-generation DESs implanted in STEMI have been associated with delayed healing and incomplete strut coverage. Therefore, in patients with implanted DES, longer duration of dual antiplatelet therapy is needed. The second-generation DESs (ZES and EES) have been improved the drug and polymer, which have been proved to improve neointima healing compared with the first generation DESs.
However, the difference of strut coverage between EES and BMS implanted in STEMI patients is unknown. In this study, we assess the neointimal coverage at 3-month and 12-month follow-up in EES and BMS implanted in patients with STEMI by optical coherence tomography.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Xience™ V stent (Abbott Vascular, Santa Clara, California, USA), Multilink-Vision stent(Abbott Vascular, Santa Clara, California, USA)
- Keywords
- Acute myocardiac infarction, Bare-metal stent, Everolimus-eluting stent, Optical coherence tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xience™ V stent (Abbott Vascular, Santa Clara, California, USA)Device
Multilink-Vision stent(Abbott Vascular, Santa Clara, California, USA)Device
| Study group | Role | What they receive |
|---|---|---|
| DES | Active comparator | Everolimus-Eluting Stent implanted in patients with ST-segment elevation myocardial infarction (STEMI) Receives: Device: Xience™ V stent (Abbott Vascular, Santa Clara, California, USA) |
| BMS | Active comparator | Bare-Metal Stent implanted in patients with ST-segment elevation myocardial infarction (STEMI) Receives: Device: Multilink-Vision stent(Abbott Vascular, Santa Clara, California, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the rate of covered struts to the EES vs BMS implanted in STEMI patients by frequency domain optical coherence tomography (FD-OCT).
The covered strut is defined as the strut has definite neointimal over it. And the rate of covered struts was calculated as the number of covered struts divided the number of total struts.
Measured: 3-month
Secondary outcomes (4)
Comparison of the rate of covered struts to the EES vs BMS implanted in STEMI patients by FD-OCT.
The covered strut is defined as the strut has definite neointimal over it. And the rate of covered struts was calculated as the number of covered struts divided the number of total struts.
Measured: 12-month
Comparison of the rate of malaposed struts to EES vs BMS implanted in STEMI patients by FD-OCT.
Strut malapposition is defined as struts detached from the vessel wall > 108μm for EES and > 101μm for BMS. The rate of malaposed struts is calculated as the number of malaposed struts divided the number of total struts.
Measured: 3-month
Comparison of the rate of malaposed struts to the EES vs BMS implanted in STEMI patients by FD-OCT.
Strut malapposition is defined as struts detached from the vessel wall > 108μm for EES and > 101μm for BMS. The rate of malaposed struts is calculated as the number of malaposed struts divided the number of total struts.
Measured: 12-month
Major adverse cardiovascular events (MACE)
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 posted12 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Why it stopped: Difficulty in enrolling the required number of participants has made it impractical to proceed with the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Bo, Harbin Medical University
- Investigators
- Bo Yu, MD,PhD, Principal investigator, The Second Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875835
- Sponsor's protocol ID
- HMUOCT-STEMI
- Acronym
- NeoCover
- Status last verified
- Nov 2024
- First submitted
- 5 Jun 2013
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Neointimal Coverage of Everolimus-Eluting Stent and Bare-metal Stent After Implantation in STEMI Patients by Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT01875835
- Acronym / sponsor ID
- NeoCover / HMUOCT-STEMI
- Conditions
- Acute Myocardial Infarction
- Keywords
- Acute myocardiac infarction, Bare-metal stent, Everolimus-eluting stent, Optical coherence tomography
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in enrolling the required number of participants has made it impractical to proceed with the trial.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 12 Jun 2013 (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.
Primary percutaneous coronary intervention (PCI) represents the preferred reperfusion strategy for patients with ST-segment elevation myocardial infarction (STEMI), since it is more effective than thrombolytic regimens in reducing adverse events, including death. Drug-eluting stents (DES) are currently being widely used in patients with STEMI. The effectiveness of DES to reduce restenosis and the need for revascularization compared with bare-metal stents (BMS) has been documented in randomized controlled trials. The first-generation DESs implanted in STEMI have been associated with delayed healing and incomplete strut coverage. Therefore, in patients with implanted DES, longer duration of dual antiplatelet therapy is needed. The second-generation DESs (ZES and EES) have been improved the drug and polymer, which have been proved to improve neointima healing compared with the first generation DESs.
However, the difference of strut coverage between EES and BMS implanted in STEMI patients is unknown. In this study, we assess the neointimal coverage at 3-month and 12-month follow-up in EES and BMS implanted in patients with STEMI by optical coherence tomography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DES | Active comparator | Device: Xience™ V stent (Abbott Vascular, Santa Clara, California, USA)Everolimus-Eluting Stent implanted in patients with ST-segment elevation myocardial infarction (STEMI) |
| BMS | Active comparator | Device: Multilink-Vision stent(Abbott Vascular, Santa Clara, California, USA)Bare-Metal Stent implanted in patients with ST-segment elevation myocardial infarction (STEMI) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18-75 years
- Acute MI with ST-segment elevation, within 12 hours from symptoms onset.
- Length of culprit lesion≤25mm.
- Vessel size in between 2.5 and 4.0 mm.
- Signed patient informed consent.
Key exclusion criteria (10 listed)
- Prior administration of thrombolytic therapy.
- Cardiogenic shock.
- Renal failure (Crea≥2.0mg/dL).
- Recent major bleeding.
- Allergy to heparin, aspirin, clopidogrel, everolimus, the polymer components of the Xience V stent, stainless steel, or contrast media.
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 |
|---|---|---|
| Xience™ V stent (Abbott Vascular, Santa Clara, California, USA) | Device | DES |
| Multilink-Vision stent(Abbott Vascular, Santa Clara, California, USA) | Device | BMS |
Primary outcome
Comparison of the rate of covered struts to the EES vs BMS implanted in STEMI patients by frequency domain optical coherence tomography (FD-OCT).
Time frame: 3-month
The covered strut is defined as the strut has definite neointimal over it. And the rate of covered struts was calculated as the number of covered struts divided the number of total struts.
4 secondary outcomes
Comparison of the rate of covered struts to the EES vs BMS implanted in STEMI patients by FD-OCT.
Time frame: 12-month
Comparison of the rate of malaposed struts to EES vs BMS implanted in STEMI patients by FD-OCT.
Time frame: 3-month
Comparison of the rate of malaposed struts to the EES vs BMS implanted in STEMI patients by FD-OCT.
Time frame: 12-month
Major adverse cardiovascular events (MACE)
Time frame: 12-month
Results and safety
The study was stopped early (reason given: Difficulty in enrolling the required number of participants has made it impractical to proceed with the trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
Related trials for Acute Myocardial Infarction
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
Enrolling by invitationPhase 3
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
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.
Bo Yu, MD,PhD principal investigator
The Second Affiliated Hospital of Harbin Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xience™ V stent (Abbott Vascular, Santa Clara, California, USA) and Multilink-Vision stent(Abbott Vascular, Santa Clara, California, USA) in people with Acute Myocardial Infarction, run by Harbin Medical University 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: stopped early, as of the sponsor's last update on 2 Dec 2024. 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.
Are results available for this study?
The study was stopped early (reason given: Difficulty in enrolling the required number of participants has made it impractical to proceed with the trial.). Results are not available in the source record.
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?
Comparison of the rate of covered struts to the EES vs BMS implanted in STEMI patients by frequency domain optical coherence tomography (FD-OCT). (time frame: 3-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 2 Dec 2024.