vitalyst early feasibility study in high-risk pci patients (vitalyst efs)

Conditions: High-risk Percutaneous Coronary Intervention; Heart Disease, Coronary

Summary: the vitalyst early feasibility study (efs) is designed to evaluate the feasibility and safety of the vitalyst system in subjects undergoing elective high-risk percutaneous coronary intervention (hr-pci).

the vitalyst efs is a prospective, open-label, single-arm, multicenter feasibility study of the vitalyst system. the vitalyst system will be used to provide temporary circulatory support in patients undergoing non-emergent high risk percutaneous interventions (hr-pci).

Eligibility criteria:
inclusion criteria: * subject provides signed informed consent. * subject is ≥ 18 years and \< 90 years of age. * subject is indicated for non-emergent pci of at least one de novo or restenotic lesion in a native coronary vessel or coronary artery bypass graft (cabg) and has left ventricular ejection fraction (lvef) ≤ 50% with the following: unprotected left main or last remaining vessel or three vessel disease (at least one ≥ 50% diameter stenosis based on center's visual assessment in all three major epicardial territories) * heart team, which must include a cardiac surgeon, agrees that hr-pci is appropriate. exclusion criteria: * subject has had stemi within 72 hours with persistent elevation of cardiac enzymes. * subject has had pre-procedure cardiac arrest requiring cpr within 24 hours of enrollment. * subject has systolic blood pressure \< 90 mmhg with evidence of end organ hypoperfusion (e.g., cool extremities or urine \< 30 ml/hour). * subject has had need for inotropes/vasopressors or mechanical circulatory support (including intra-aortic balloon pump) in the previous 24 hours to maintain a systolic blood pressure ≥ 90 mmhg. * subject has left ventricular mural thrombus. * subject has a prosthetic aortic valve. * subject has pericarditis or constrictive heart disease (constrictive pericarditis or restrictive cardiomyopathy). * subject has moderate or greater aortic valve stenosis or moderate or greater aortic valve insufficiency (by echocardiographic assessment, graded as \> 2+). * subject has abnormalities of the aorta that preclude safe delivery of the device, including severe calcification, tortuosity, aneurysm, or prior surgery. * subject has pvd preventing passage of the device (e.g., calcification, small caliber) or tortuosity that would preclude safe placement of the introducer sheath as per the ifu. * subject is not on dialysis and has creatinine \> 4 mg/dl. * subject has a history of liver dysfunction (childs class c) with elevation of liver enzymes and bilirubin \> 3× uln or inr ≥ 2. * subject has had a recent (within 30 days) stroke or tia. * subject has known hypersensitivity to intravenous contrast agents that cannot be adequately pre-medicated or has known hypersensitivity to heparin, aspirin, adp receptor inhibitors or nitinol. * subject has current or a history of heparin induced thrombocytopenia. * subject has uncorrected abnormal coagulation or platelet count ≤ 75,000/mm³ or inr ≥ 2.0. * subject has significant right heart failure based on any one of the following criteria: rvswi \ 3.6 woods units or pulmonary artery pulsatility index \< 1.85 * subject requires non-elective mechanical ventilation. * subject has an atrial or ventricular septal defect (including post-infarct vsd). * subject has left ventricular rupture. * subject has cardiac tamponade. * subject has severe pulmonary disease (fev1 \< 1l). * subject has sustained or non-sustained ventricular tachycardia. * subject is breast feeding or is pregnant. * subject has infection of the proposed procedural access site or active systemic infection. * subject has any condition that requires premature discontinuation of recommended antiplatelet and/or anticoagulant therapy before 90 days following the index procedure. * any use of a mechanical circulatory support device within 14 days prior to the index procedure. * staged pci is planned within 90 days following device removal. * subject is participating in another investigational drug or device study that has not reached its primary endpoint. * subject has other disease condition(s) resulting in the subject being unsuitable for participation in the clinical trial (e.g., advanced malignancy with limited expected survival) * subject has other disease condition(s) which the investigator has determined may cause non-compliance to the study requirements.