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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
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

First Posted
March 26, 2022
Last Updated
May 2, 2022
Sponsor
Abbott Medical Devices
Collaborators
Clinical Accelerator
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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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