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

Sponsor
Cardiovascular Systems Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT05315544
Collaborator
Clinical Accelerator (Other)
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2
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: CSI pVAD system
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
5 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
CSI Percutaneous Ventricular Assist Device (pVAD) First in Human Study
Actual Study Start Date :
Mar 14, 2022
Actual Primary Completion Date :
Mar 16, 2022
Actual Study Completion Date :
Mar 16, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: CSI pVAD

Device: CSI 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.

Outcome Measures

Primary Outcome Measures

  1. Procedural success [Intraprocedural]

    Delivery of the device to the correct anatomical position, successful operation and removal of the CSI pVAD system

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tbilisi Heart & Vascular Tbilisi Georgia

Sponsors and Collaborators

  • Cardiovascular Systems Inc
  • Clinical Accelerator

Investigators

  • Study Director: Jeff Chambers, MD, Cardiovascular Systems Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cardiovascular Systems Inc
ClinicalTrials.gov Identifier:
NCT05315544
Other Study ID Numbers:
  • CLN-0015-P
First Posted:
Apr 7, 2022
Last Update Posted:
May 3, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Cardiovascular Systems Inc
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 3, 2022