Cardiovascular Systems Inc. (CSI) pVAD First in Human Study
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Georgia
Study Type
Interventional
Intervention
CSI pVAD system
Sponsored by
About this trial
This is an interventional device feasibility trial for Coronary Artery Disease focused on measuring pVAD, High risk PCI, Cardiovascular Systems, Inc., Mechanical Circulatory Support (MCS)
Eligibility Criteria
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
Sites / Locations
- Tbilisi Heart & Vascular
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CSI pVAD
Arm Description
Outcomes
Primary Outcome Measures
Procedural success
Delivery of the device to the correct anatomical position, successful operation and removal of the CSI pVAD system
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05315544
First Posted
March 26, 2022
Last Updated
May 2, 2022
Sponsor
Abbott Medical Devices
Collaborators
Clinical Accelerator
1. Study Identification
Unique Protocol Identification Number
NCT05315544
Brief Title
Cardiovascular Systems Inc. (CSI) pVAD First in Human Study
Official Title
CSI Percutaneous Ventricular Assist Device (pVAD) First in Human Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 14, 2022 (Actual)
Primary Completion Date
March 16, 2022 (Actual)
Study Completion Date
March 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
Collaborators
Clinical Accelerator
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will collect initial clinical data on the CSI pVAD system to inform device design and finalization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
pVAD, High risk PCI, Cardiovascular Systems, Inc., Mechanical Circulatory Support (MCS)
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CSI pVAD
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
CSI pVAD system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Procedural success
Description
Delivery of the device to the correct anatomical position, successful operation and removal of the CSI pVAD system
Time Frame
Intraprocedural
Title
Intraprocedural Major Device-Related Adverse Events
Description
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.
Time Frame
24-hours Post-Index Procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Chambers, MD
Organizational Affiliation
Abbott Medical Devices
Official's Role
Study Director
Facility Information:
Facility Name
Tbilisi Heart & Vascular
City
Tbilisi
Country
Georgia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cardiovascular Systems Inc. (CSI) pVAD First in Human Study
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