Coronary Artery Disease
Conditions
Keywords
pVAD, High risk PCI, Cardiovascular Systems, Inc., Mechanical Circulatory Support (MCS)
Brief summary
This study will collect initial clinical data on the CSI pVAD system to inform device design and finalization.
Interventions
DEVICECSI pVAD system
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.
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Male or non- pregnant female ≥ 18 years of age 2. Life expectancy ≥ 1 year 3. Ejection Fraction (EF) \>15% and ≤ 40% 4. Scheduled for an elective high risk percutaneous coronary intervention
Exclusion criteria
1. 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 2. Pre-Procedure cardiac arrest within 24 hours of enrollment requiring cardiopulmonary resuscitation 3. Cardiogenic shock 4. Left ventricular (LV) mural thrombus 5. Presence of a prosthetic valve or a heart constrictive device 6. Aortic stenosis 7. Moderate or severe aortic regurgitation (≥ 2+ by echo) 8. 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 9. Severe aortic tortuosity 10. Severe aortic calcification 11. Vasculature will not tolerate a right heart catheterization 12. Renal dysfunction (serum creatinine ≥ 2.5 mg/dl) or requirement for hemodialysis 13. 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 14. Uncorrectable abnormal coagulation parameters 15. History of heparin induced thrombocytopenia 16. Sustained ventricular tachycardia 17. Stroke or transient ischemic attack (TIA) within 6 months or any permanent neurological deficit 18. Chronic anemia (hemoglobin \< 8 g/dL) 19. Subject may require long term support with a commercially available hemodynamic support device 20. Active systemic infection requiring oral or intravenous antibiotics 21. Allergy or intolerance to ionic and nonionic contrast media, anticoagulants, or antiplatelet therapy drugs that cannot be adequately premedicated 22. Allergy or intolerance to system components 23. Participation in another investigational drug or device study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success | Intraprocedural | Delivery of the device to the correct anatomical position, successful operation and removal of the CSI pVAD system |
| Intraprocedural Major Device-Related Adverse Events | 24-hours Post-Index Procedure | 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. |
Countries
Georgia
Outcome results
None listed