A prospective, randomized, controlled multi-site feasibility trial to assess the potential
role of the IMPELLA® 2.5 System in reducing infarct size in patients with ST-elevation
myocardial infarction (STEMI)
Device: Impella 2.5 support
Other: Standard of care (Control)
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Full eligibility criteria for NCT01319760
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Age ≥ 18 years
Signed Informed Consent
Acute anterior STEMI with ≥2 mm of ST-segment elevation in 2 or more contiguous anterior leads or ≥ 4 mm in total in the anterior leads, OR, Large Inferior STEMI with
≥2 mm of ST-segment elevation in 2 or more inferior leads AND EITHER ≥1 mm ST-segment elevation in V1 OR ≥1 mm of ST-segment depression in ≥2 contiguous anterior leads
Primary PCI performed within 5 hours of the onset of symptoms
Patient undergoing emergent primary PCI of one culprit lesion in one major native epicardial coronary vessel
Successful revascularization of the culprit native coronary artery with TIMI Flow Grade of 3 at the end of PCI
Cardiac arrest requiring CPR within 24 hours prior to enrollment
Current cardiogenic shock
Left Bundle Branch Block (new or old)
Known history of prior MI
Prior coronary artery bypass graft surgery
Known mural thrombus in the left ventricle or contraindication to left ventriculography
Presence of a mechanical aortic valve
Documented presence of moderate to severe aortic stenosis or moderate to severe aortic insufficiency.
Known history of severe kidney dysfunction.
Known contraindication to MRI (implanted metallic or magnetically activated device; claustrophobia, inability to hold breath for 15 seconds).
History of recent (within 1 month) stroke or TIA
History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
Administration of fibrinolytic therapy within 24 hours
Known hypersensitivity or contraindication to any of the following: Heparin, pork or pork products; Aspirin, All of the following: Clopidogrel, Ticlopidine, Prasugrel
Contrast media Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device.
Severe peripheral arterial obstructive disease that would preclude the IMPELLA® System placement
Requirement to treat two or more culprit vessels during primary PCI, or plan for staged coronary revascularization (PCI or CABG) within the next 30 days.
Inability to place Impella within 6 hours of the onset of symptoms, should patient be randomized to this arm.
All locations for NCT01319760
Trial results for NCT01319760
Participant Flow: Overall Study
Control (Standard of Care PCI Without Using Impella)
0 / 0
Completed / Started
Experimental (PCI Preceded With Impella 2.5)
5 / 5
Completed / Started
Serious Adverse Events
4 / 10
Affected / At Risk
Other Adverse Events
4 / 5
Affected / At Risk
View full eligibility
Tris trial is registered with FDA with number: NCT01319760. The sponsor of the trial is Abiomed Inc. and it is looking for 5 volunteers for the current phase.
Official trial title: MINI-AMI: Minimizing INfarct Size With IMPELLA® 2.5 System Following PCI for Acute Myocardial Infarction
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