Cardiovascular Systems Inc. (CSI) pVAD First in Human Study

Study Overview
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Brief Summary
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This study will collect initial clinical data on the CSI pVAD system to inform device design and finalization.

Official Title
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CSI Percutaneous Ventricular Assist Device (pVAD) First in Human Study

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: CSI pVAD system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non- pregnant female ≥ 18 years of age Life expectancy ≥ 1 year Ejection Fraction (EF) >15% and ≤ 40% Scheduled for an elective high risk percutaneous coronary intervention Exclusion Criteria: Hemodynamically unstable MI with elevated cardiac biomarker and no evidence of at least 1 consecutive CK-MB or troponin value trending downward from a previous value OR ST-Elevation Myocardial Infarction (STEMI) within 14 days of Index Procedure Pre-Procedure cardiac arrest within 24 hours of enrollment requiring cardiopulmonary resuscitation Cardiogenic shock Left ventricular (LV) mural thrombus Presence of a prosthetic valve or a heart constrictive device Aortic stenosis Moderate or severe aortic regurgitation (≥ 2+ by echo) Severe peripheral vascular disease that will preclude the use of a 12F access sheath, which is required for the insertion of the CSI pVAD catheter Severe aortic tortuosity Severe aortic calcification Vasculature will not tolerate a right heart catheterization Renal dysfunction (serum creatinine ≥ 2.5 mg/dl) or requirement for hemodialysis Liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3X upper lab normal (ULN) or Internationalized Normalized Ratio (INR) ≥ 2 or lactate dehydrogenase (LDH) > 2.5X ULN Uncorrectable abnormal coagulation parameters History of heparin induced thrombocytopenia Sustained ventricular tachycardia Stroke or transient ischemic attack (TIA) within 6 months or any permanent neurological deficit Chronic anemia (hemoglobin < 8 g/dL) Subject may require long term support with a commercially available hemodynamic support device Active systemic infection requiring oral or intravenous antibiotics Allergy or intolerance to ionic and nonionic contrast media, anticoagulants, or antiplatelet therapy drugs that cannot be adequately premedicated Allergy or intolerance to system components Participation in another investigational drug or device study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: CSI pVAD<br> | Device: CSI pVAD system<br>* The CSI percutaneous ventricular assist device (pVAD) is being investigated as a temporary left ventricular system intended to support and/or provide hemodynamic stability during high-risk percutaneous coronary interventions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success | Delivery of the device to the correct anatomical position, successful operation and removal of the CSI pVAD system | Intraprocedural | 
| Intraprocedural Major Device-Related Adverse Events | Composite incidence of: Cardiovascular death Clinically significant myocardial infarction (MI) defined as the composite of MI events per Society for Cardiovascular Angiography and Intervention (SCAI) periprocedural MI and Fourth Universal MI definitions Any repeat revascularization (PCI or CABG) Stroke defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction. | 24-hours Post-Index Procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pVAD, High risk PCI, Cardiovascular Systems, Inc., Mechanical Circulatory Support (MCS)