ST Elevation Myocardial Infarctione-MASTERNCT02292823
MGuard™ Prime Embolic Protection Stent in Patients With Acute ST Elevation Myocardial Infarction
An observational study of ST Elevation Myocardial Infarction, run by InspireMD at 1 site in Netherlands.
Trial summary
Prospective, non-randomized, single arm, multicenter observational study. The objective is to evaluate the safety and efficacy of the MGuard™ Prime stent in the treatment of de novo stenotic lesions in coronary arteries in patients undergoing primary percutaneous coronary intervention (PCI) due to acute ST elevation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Myocardial Infarction
- What is being tested?
- MGuard™ Prime Embolic Protection Stent System
- Type of treatment
- Medical device
- How many people
- 63 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2014to Sep 2016
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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
Study population: Subjects undergoing primary revascularization for STEMI and who are intended to undergo primary PCI with the MGuard™ Prime Embolic Protection Stent System.
Who may be able to join
- Subject is >18 years of age.
- Subject is experiencing clinical symptoms consistent with ST elevation acute myocardial infarction (STEMI) of >30 minutes and <24 hours.
- Based on coronary anatomy, primary PCI is indicated for the culprit lesion with anticipated use of stenting.
- Subject agrees to all required follow-up procedures and visits and has provided informed consent where required.
- The target lesion is a de novo lesion in a native coronary artery.
- The reference vessel diameter (RVD) of the infarct lesion is 2.75-4.0 mm by visual assessment.
Who cannot join
- Subject undergoing cardiopulmonary resuscitation.
- 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).
- Co-morbid condition(s) or others that could limit the subject's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial.
- Target lesion involves a bifurcation with a side branch >/=2.0 mm in diameter.
- In the Investigator's opinion the lesion/vessel is unsuitable for treatment with the MGuard™ Prime Embolic Protection Stent System for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: e-MASTER Registry: MGuard™ Prime Embolic Protection Stent in Patients With Acute ST Elevation Myocardial Infarction
Prospective, non-randomized, single arm, multicenter observational study. The objective is to evaluate the safety and efficacy of the MGuard™ Prime stent in the treatment of de novo stenotic lesions in coronary arteries in patients undergoing primary percutaneous coronary intervention (PCI) due to acute ST elevation myocardial infarction (STEMI) in a real-world setting.
- Conditions
- ST Elevation Myocardial Infarction
- Being tested
- MGuard™ Prime Embolic Protection Stent System
- Keywords
- STEMI, heart attack, stent, Bare Metal Stent, myocardial infarction, PCI
- Medical subject headings
- ST Elevation Myocardial Infarction, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGuard™ Prime Embolic Protection Stent SystemDevice
Also called MGuard™ Prime EPS
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete ST-segment resolution
Measured: 1 day
All cause death or MI at 30 days
Measured: 30 days
Secondary outcomes (4)
TIMI flow grade
Measured: 1 day
Major Adverse Cardiac Events rate (MACE): cardiac death, re-MI, clinically-driven target lesion revascularization (TLR)
Measured: Discharge, 30 days, 6 months, 12 months
Acute success rates
Measured: 1 day
Stent thrombosis rate
Measured: Discharge, 30 days, 6 months,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2015 (estimated)
- Study completionSep 2016 (estimated)
Why it stopped: Enrolment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- InspireMD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292823
- Sponsor's protocol ID
- IMD-13
- Acronym
- e-MASTER
- Status last verified
- Aug 2015
- First submitted
- 13 Nov 2014
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- e-MASTER Registry: MGuard™ Prime Embolic Protection Stent in Patients With Acute ST Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02292823
- Acronym / sponsor ID
- e-MASTER / IMD-13
- Conditions
- ST Elevation Myocardial Infarction
- Keywords
- STEMI, heart attack, stent, Bare Metal Stent, myocardial infarction, PCI
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Enrolment rate
- Enrolment
- 63 participants (actual)
- Lead sponsor
- InspireMDIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 17 Nov 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.
Prospective, non-randomized, single arm, multicenter observational study. The objective is to evaluate the safety and efficacy of the MGuard™ Prime stent in the treatment of de novo stenotic lesions in coronary arteries in patients undergoing primary percutaneous coronary intervention (PCI) due to acute ST elevation myocardial infarction (STEMI) in a real-world setting.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects undergoing primary revascularization for STEMI and who are intended to undergo primary PCI with the MGuard™ Prime Embolic Protection Stent System.
Key inclusion criteria (6 listed)
- Subject is >18 years of age.
- Subject is experiencing clinical symptoms consistent with ST elevation acute myocardial infarction (STEMI) of >30 minutes and <24 hours.
- Based on coronary anatomy, primary PCI is indicated for the culprit lesion with anticipated use of stenting.
- Subject agrees to all required follow-up procedures and visits and has provided informed consent where required.
- The target lesion is a de novo lesion in a native coronary artery.
Key exclusion criteria (5 listed)
- Subject undergoing cardiopulmonary resuscitation.
- 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).
- Co-morbid condition(s) or others that could limit the subject's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial.
- Target lesion involves a bifurcation with a side branch >/=2.0 mm in diameter.
- In the Investigator's opinion the lesion/vessel is unsuitable for treatment with the MGuard™ Prime Embolic Protection Stent System for any reason.
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 Embolic Protection Stent SystemAlso: MGuard™ Prime EPS | Device | – |
Primary outcome
Complete ST-segment resolution
Time frame: 1 day
All cause death or MI at 30 days
Time frame: 30 days
4 secondary outcomes
TIMI flow grade
Time frame: 1 day
Major Adverse Cardiac Events rate (MACE): cardiac death, re-MI, clinically-driven target lesion revascularization (TLR)
Time frame: Discharge, 30 days, 6 months, 12 months
Acute success rates
Time frame: 1 day
Stent thrombosis rate
Time frame: Discharge, 30 days, 6 months,12 months
Results and safety
The study was stopped early (reason given: Enrolment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 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.
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?
An observational study of ST Elevation Myocardial Infarction, run by InspireMD at 1 site in Netherlands.
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 6 inclusion and 5 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 Sep 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 Netherlands. 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: Enrolment rate). 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?
Complete ST-segment resolution (time frame: 1 day). The study lists 2 primary outcomes in all. 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 Sep 2015.