Status:
TERMINATED
MGuard™ Prime Embolic Protection Stent in Patients With Acute ST Elevation Myocardial Infarction
Lead Sponsor:
InspireMD
Conditions:
ST Elevation Myocardial Infarction
Eligibility:
All Genders
18+ years
Brief 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 i...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT02292823
Start Date
April 1 2014
End Date
September 1 2016
Last Update
September 2 2015
Active Locations (1)
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1
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands