This is a prospective, multi-center, single-arm study designed to assess the safety and performance of the Pristine™ Long-Term Hemodialysis Catheter.
A total of 142 patients will be enrolled and have the Pristine™ Long-Term Hemodialysis Catheter placed. Under the current enrollment assumptions, up to 15 investigational sites in the United States (US) will participate. Eligible participants will have End Stage Renal Disease requiring hemodialysis through a tunneled dialysis catheter. Follow-up for all enrolled participants will be performed at 1-month, 3-months, 6-months, and 12-months post-Index Procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
142
Placement of the Pristine™ Long-Term Hemodialysis Catheter Placement.
Trinity Research Group LLC
Dothan, Alabama, United States
Yale University
New Haven, Connecticut, United States
Louisiana State University Health Shreveport Medical Center
Shreveport, Louisiana, United States
Henry Ford Health System
Detroit, Michigan, United States
Overall Complication Rate of the Pristine™ Catheter
The combined Primary Endpoint is the overall rate of infectious complications and non-infectious complications requiring revision to maintain patency and improve access performance, evaluated against a performance goal (PG) derived from the Dialysis Outcomes and Practice Patterns Study (DOPPS) data.
Time frame: At 3 months post index procedure.
Rate of Freedom From Catheter-related Bloodstream Infection (CRBSI)
2019 KDOQI Guidelines for CRBSI defined as, clinical manifestations and at least 1 positive blood culture result from a peripheral source (dialysis circuit or vein) and no other apparent source, with either positive semiquantitative (\>15 CFU/catheter segment, hub or tip) or quantitative (\>102 CFU/catheter segment, eg, hub or tip) culture, whereby the same organism (species and antibiogram) is isolated from the catheter segment (eg, hub or tip) and a peripheral source (dialysis circuit or vein) blood sample.
Time frame: 1-month Post-Index Procedure.
Rate of Freedom From Device and/or Procedure-related Adverse Events
Number of participants free from Device and/or Procedure-related adverse events.
Time frame: 1-month Post-Index Procedure.
Rate of Technical Success
Number of Participants with successful placement of the Pristine™ Long-Term Hemodialysis Catheter
Time frame: At time of Index Procedure.
Overall Participant Survival Rate
Number of participants that have not died from any catheter related complication.
Time frame: 1-month Post-Index Procedure.
Overall Catheter Survival Rate
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North Carolina Nephrology, PA
Raleigh, North Carolina, United States
JML Research Associates
Providence, Rhode Island, United States
Number of participants with whom the Pristine™ Catheters have not been removed for any cause.
Time frame: 1-month Post-Index Procedure
Overall Patency Rate
Number of participants with their Pristine™ catheter having the ability to achieve a mean dialysis blood flow of ≥300mL/min without need for additional interventions.
Time frame: 1-month Post-Index Procedure