VITALYST Early Feasibility Study in High-Risk PCI Patients (VITALYST EFS)

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).

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 < 0.30 mmHg·L/m² or PVR > 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.