Protected PCI Study

Study Overview
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Brief Summary
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A Prospective, multi-center, single-arm post-approval study of the IMPELLA® 2.5 System in Non Emergent High Risk PCI patients.

Detailed Description
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The objective of the study is to assess the safety and efficacy of the IMPELLA® 2.5 System in subjects undergoing non-emergent high-risk percutaneous coronary intervention (PCI) post market approval. The primary endpoint will be a composite clinical endpoint of major adverse events through 90 days following the PCI procedure. The outcome will be compared to the pre specified performance goal of 53%.

Official Title
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PROTECTED PCI STUDY: A Prospective Clinical Trial For Patients Undergoing Protected Percutaneous Coronary Intervention With IMPELLA® 2.5 System

Conditions
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Heart Failure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Informed Consent Subject is indicated for a NON emergent percutaneous treatment of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft per the judgement of a heart team including a surgeon Age eligible (18 ≤ Age ≤ 90) Subject presents with: Ejection Fraction≤ 35% AND at least one of the following criteria: Intervention on the last patent coronary conduit, or Intervention on an unprotected left main coronary artery Or Ejection Fraction ≤ 30% and intervention in patient presenting with triple vessel disease. *three-vessel or triple vessel disease is defined as at least one significant stenosis* in all three major epicardial territories: Left Anterior Descending (LAD) Artery and/or side branch, left circumflex (LCX) artery and/or side branch, Right Coronary Artery (RCA) and or side branch. *Significant stenosis is defined as at least 50% diameter stenosis by visual estimate or any total occlusion. In the case of left coronary artery dominance, a lesion in the LAD and the proximal LCX qualifies as three-vessel disease. Exclusion Criteria: 1. ST Myocardial Infarction within 24 hours or CK-MB that have not normalized 2. Pre-procedure cardiac arrest within 24 hours of enrolment requiring CPR 3. Subject is inotrope dependent or in cardiogenic shock defined as: Hypotension (systolic BP < 90 mmHg for > 30 minutes or the need for supportive measures to maintain a systolic BP of greater than or equal to 90 mmHg) AND end organ hypoperfusion (cool extremities OR a urine output of < 30 ml/hour) 4. Mural thrombus in the left ventricle 5. Patient scheduled for revascularization of a total chronic occlusion (CTO) or transcatheter aortic valve replacement within 1 year of index procedure. 6. The presence of a mechanical aortic valve or heart constrictive device 7. Documented presence of aortic stenosis (aortic stenosis graded as ≥ +2 equivalent to an orifice area of 1.5cm2 or less. 8. Documented presence of moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥ +2) 9. Severe peripheral arterial obstructive disease that would preclude the IMPELLA System device placement 10. Abnormalities of the aorta that would preclude surgery, including aneurysms and extreme tortuosity or calcifications 11. Subject with renal failure (creatinine ≥ 4mg/dL or on dialysis) 12. Subject has history of debilitating liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3x ULN or INR (Internationalized Normalized Ratio) ≥ 2 13. Subject has uncorrectable abnormal coagulation parameters (defined as platelet count ≤75,000/mm3 or INR ≥2.0.) 14. History of recent (within 1 month) stroke or TIA 15. Allergy or intolerance to heparin, aspirin, ADP receptor inhibitors(clopidogrel and ticlid) or contrast media 16. Subject with documented heparin induced thrombocytopenia 17. Participation in the active follow-up phase of another clinical study of an investigational drug or device

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A composite rate of the following intra-procedural and post-procedural major adverse events (MAE) at 90 days post index procedure. | The primary endpoint is defined as a composite rate of the major adverse events at 90 days post index procedure | 90 days post index procedure |