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

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

Official Title
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VITALYST EFS: VITALYST Temporary Percutaneous Transvalvular Circulatory Support System Early Feasibility Study

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

Intervention / Treatment
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* Device: VITALYST System


Participation Criteria
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Eligibility Criteria
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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 units43 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 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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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Risk PCI Patients<br>Patients undergoing non-emergent, high-risk percutaneous coronary interventions | Device: VITALYST System<br>* The VITALYST System is a temporary ventricular support device indicated for use during high-risk percutaneous coronary interventions (HR-PCI) performed electively in hemodynamically stable subjects with severe coronary artery disease.<br>* Other names: Percutaneous Mechanical Circulatory Support;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Success | The primary endpoint consists of the composite endpoint of Clinical Success (measured at exit from the catheterization laboratory), which is defined as follows. Technical Success: Successful delivery of the device to the correct anatomical position; and Successful operation and removal of the VITALYST circulatory support system No conversion to open heart surgery No procedural mortality | Immediately after the intervention/procedure |