MGuard™ Prime Embolic Protection Stent in Patients With Acute ST Elevation Myocardial Infarction
NCT ID: NCT02292823
Last Updated: 2015-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
63 participants
OBSERVATIONAL
2014-04-30
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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MGuard™ Prime Embolic Protection Stent System
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject is experiencing clinical symptoms consistent with ST elevation acute myocardial infarction (STEMI) of \>30 minutes and \<24 hours.
3. Based on coronary anatomy, primary PCI is indicated for the culprit lesion with anticipated use of stenting.
4. Subject agrees to all required follow-up procedures and visits and has provided informed consent where required.
5. The target lesion is a de novo lesion in a native coronary artery.
6. The reference vessel diameter (RVD) of the infarct lesion is 2.75-4.0 mm by visual assessment.
Exclusion Criteria
2. 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).
3. 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.
4. Target lesion involves a bifurcation with a side branch \>/=2.0 mm in diameter.
5. In the Investigator's opinion the lesion/vessel is unsuitable for treatment with the MGuard™ Prime Embolic Protection Stent System for any reason.
18 Years
ALL
No
Sponsors
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InspireMD
INDUSTRY
Responsible Party
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Locations
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Onze Lieve Vrouwe Gasthuis
Amsterdam, , Netherlands
Countries
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Other Identifiers
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IMD-13
Identifier Type: -
Identifier Source: org_study_id
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