ST Segment Elevated Myocardial InfarctionPhase 4MASTER-OCTNCT02222116
OCT Study of the MGuard Prime Stent in Patients With Heart Attacks
A Phase 4 study testing MGuard Prime in people with ST Segment Elevated Myocardial Infarction, run by InspireMD at 1 site in United Kingdom.
Trial summary
The objective is to demonstrate that the Flow Area within a blocked coronary vessel as assessed by OCT is greater with the MGuard Prime stent compared to non-mesh control stent (BMS/DES) in subjects undergoing primary PCI for ST-segment elevation MI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Segment Elevated Myocardial Infarction
- What is being tested?
- MGuard Prime
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2015to Jan 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is >18 years of age.
- Subject is experiencing clinical symptoms consistent with acute myocardial infarction (AMI) of >30 minutes and ≤12 hours in duration.
- ST-segment elevation ≥1 mm per lead in ≥2 contiguous leads is present in at least one ECG prior to consent.
- Subject agrees to all required follow-up procedures and visits.
- Subject provides written, informed consent.
- The target lesion is a single de novo lesion in a native coronary artery.
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- Based on coronary anatomy, PCI is indicated for the culprit lesion with anticipated use of stenting.
- TIMI flow of 0/1 is present at baseline and TIMI flow of 2/3 is present prior to randomization.
- The reference vessel diameter (RVD) of the infarct lesion is 2.75-4.0 mm by visual assessment, assessed after TIMI 2/3 flow is restored.
- The entire lesion length requiring treatment is ≤33 mm by visual assessment, assessed after TIMI 2/3 flow is restored.
Who cannot join
- Currently enrolled in another investigational device or drug trial that has not reached the primary endpoint or that clinically interferes with the current study endpoints.
- A previous coronary interventional procedure of any kind within 30 days - - - Female patients of childbearing potential.
- Subject undergoing cardiopulmonary resuscitation (patients in whom cardiopulmonary resuscitation was successfully performed and in whom normal mental status was achieved, may be enrolled).
- Cardiogenic shock (SBP <80 mmHg for >30 minutes, or requiring IV pressors or intra-aortic balloon bump (IABP) or other hemodynamic support device for hypotension).
- Prior administration of thrombolytic therapy for the current admission
- Concurrent medical condition with a life expectancy of less than 12 months.
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- History of cerebrovascular accident or transient ischemic attack within the last 6 months, or any permanent neurologic deficit
- Prior intracranial bleed at any time, or known intracranial pathology (e.g. tumor, arteriovenous malformation, or aneurysm).
- Active or recent major bleeding within 6 months.
- History of bleeding diathesis or coagulopathy or inability to accept blood transfusions.
- Known hypersensitivity or contraindication to i) aspirin; or ii) heparin and bivalirudin; or iii) clopidogrel, prasugrel and ticagrelor; or iv) cobalt or nickel; or v) contrast media, which cannot be adequately pre-medicated (prior anaphylaxis, however, is an absolute contraindication to enrollment).
- Known calculated creatinine clearance <30 mL/min, hemoglobin <10 g/dL or platelet count <150,000 for the present admission or within 7 days prior to index procedure, if available. NOTE: Baseline labs do not have to be available to consent patient. If laboratory results become available only after randomization, and do not meet inclusion and exclusion criteria, the patient will not be de-registered from the study.
- Surgery planned or any other reason necessitating discontinuation of dual anti-platelet therapy (aspirin and an ADP antagonist) within 6 months.
- Rheolytic thrombectomy, a PTCA balloon with diameter >2.0 mm, or any other device (other than guide wire or simple manual aspiration) is required to restore TIMI 2/3 flow in the infarct vessel.
- Unprotected left main stenosis ≥50% or planned left main intervention.
- Any non-study lesion in the infarct artery with visually estimated diameter stenosis ≥50% and reference vessel diameter ≥2.0 mm or that will require treatment during the index procedure.
- Multi-vessel or multi-lesion intervention required during the index procedure.
- Excessive tortuosity, calcification or diffuse distal disease is present either proximal to, at or distal to the target lesion making it unlikely that the OCT catheter or stent will be able to reach or can be deployed across the target lesion with full expansion.
- Target lesion is a bifurcation with a side branch ≥2.0 mm in diameter.
- Target lesion is at the site of or within a vessel with a previously implanted stent.
- Target lesion is within a bypass graft conduit, or can only be reached by passing the study stent through a bypass graft conduit.
- Aortic dissection or mechanical complication of STEMI (papillary muscle rupture, ventricular septal defect or free wall rupture with or without pseudoaneurysm) identified by left ventriculography or any other modality (such as echocardiography, MRI, CT, physical exam).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: OCT Study of the MGuard Prime Embolic Protection Stent in Patients With Acute ST-segment Elevation Myocardial Infarction
The objective is to demonstrate that the Flow Area within a blocked coronary vessel as assessed by OCT is greater with the MGuard Prime stent compared to non-mesh control stent (BMS/DES) in subjects undergoing primary PCI for ST-segment elevation MI. The study hypothesis is that end of procedure flow area is greater with the MGuard Prime compared with stenting with a non-mesh DES or BMS.
- Being tested
- MGuard Prime, Control BMS DES
- Keywords
- STEMI, BMS, DES, mesh
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGuard PrimeDevice
Control BMS DESDevice
| Study group | Role | What they receive |
|---|---|---|
| MGuard Prime | Experimental | MGuard Prime Receives: Device: MGuard Prime |
| Control | Active comparator | BMS or DES Receives: Device: Control BMS DES |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the minFA as measured by OCT at end of primary PCI (after stent deployment but before postdilatation), powered to demonstrate superiority of the MGuard Prime stent compared to the control arm.
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study startOct 2015
- Primary completionNov 2015 (estimated)
- Study completionJan 2016 (estimated)
Why it stopped: Market move to DES
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Segment Elevated 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- InspireMD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ori Ben Yehuda, MD, Principal investigator, CRFSimon Eccleshall, MD, Principal investigator, Norfolk and Norwhich Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222116
- Sponsor's protocol ID
- IMD-15
- Acronym
- MASTER-OCT
- Status last verified
- Mar 2015
- First submitted
- 19 Aug 2014
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCT Study of the MGuard Prime Embolic Protection Stent in Patients With Acute ST-segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02222116
- Acronym / sponsor ID
- MASTER-OCT / IMD-15
- Keywords
- STEMI, BMS, DES, mesh
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Market move to DES
- Enrolment
- 0 participants (actual)
- Lead sponsor
- InspireMDIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 21 Aug 2014 (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.
The objective is to demonstrate that the Flow Area within a blocked coronary vessel as assessed by OCT is greater with the MGuard Prime stent compared to non-mesh control stent (BMS/DES) in subjects undergoing primary PCI for ST-segment elevation MI. The study hypothesis is that end of procedure flow area is greater with the MGuard Prime compared with stenting with a non-mesh DES or BMS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MGuard Prime | Experimental | Device: MGuard PrimeMGuard Prime |
| Control | Active comparator | Device: Control BMS DESBMS or DES |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject is >18 years of age.
- Subject is experiencing clinical symptoms consistent with acute myocardial infarction (AMI) of >30 minutes and ≤12 hours in duration.
- ST-segment elevation ≥1 mm per lead in ≥2 contiguous leads is present in at least one ECG prior to consent.
- Subject agrees to all required follow-up procedures and visits.
- Subject provides written, informed consent.
Key exclusion criteria (22 listed)
- Currently enrolled in another investigational device or drug trial that has not reached the primary endpoint or that clinically interferes with the current study endpoints.
- A previous coronary interventional procedure of any kind within 30 days - - - Female patients of childbearing potential.
- Subject undergoing cardiopulmonary resuscitation (patients in whom cardiopulmonary resuscitation was successfully performed and in whom normal mental status was achieved, may be enrolled).
- Cardiogenic shock (SBP <80 mmHg for >30 minutes, or requiring IV pressors or intra-aortic balloon bump (IABP) or other hemodynamic support device for hypotension).
- Prior administration of thrombolytic therapy for the current admission
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 |
|---|---|---|
| MGuard Prime | Device | MGuard Prime |
| Control BMS DES | Device | Control |
Primary outcome
The primary endpoint is the minFA as measured by OCT at end of primary PCI (after stent deployment but before postdilatation), powered to demonstrate superiority of the MGuard Prime stent compared to the control arm.
Time frame: immediate
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
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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.
Ori Ben Yehuda, MD principal investigator
CRF
Simon Eccleshall, MD principal investigator
Norfolk and Norwhich Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MGuard Prime in people with ST Segment Elevated Myocardial Infarction, run by InspireMD at 1 site in United Kingdom.
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 10 inclusion and 22 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: withdrawn, as of the sponsor's last update on 31 Mar 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 United Kingdom. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
The primary endpoint is the minFA as measured by OCT at end of primary PCI (after stent deployment but before postdilatation), powered to demonstrate superiority of the MGuard Prime stent compared to the control arm. (time frame: immediate). 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 31 Mar 2015.