The Pristine Post-Market Study

Not Applicable

Terminated

Conditions: Hemodialysis Complication
Hemodialysis Catheter Infection
Hemodialysis Access Failure
Kidney Failure, Chronic
End Stage Renal Disease
Central Venous Catheter Related Bloodstream Infection

Interventions: Device: Pristine™ Long-Term Hemodialysis Catheter

Registration Number: NCT05228132

Lead Sponsor: C. R. Bard

Brief Summary: This is a prospective, multi-center, single-arm study designed to assess the safety and performance of the Pristine™ Long-Term Hemodialysis Catheter.

Detailed Description: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 142

Inclusion Criteria

The participant or legally designated representative must voluntarily sign and date the approved Informed Consent Form (ICF) prior to collection of study-specific data or performance of study-specific procedures.
The participant must be willing and able to comply with protocol requirements, including all study visits and procedures.
The participant must be either a male or non-pregnant female ≥18 years of age.
The participant must have a diagnosis of End Stage Renal Disease with indication for a tunneled dialysis catheter creation.
Participant must require chronic hemodialysis treatments 3 times per week with intended use of the Pristine™ Long-Term Hemodialysis Catheter.
The participant meets the indications for hemodialysis use and does not meet any of the contraindications per the Pristine Instructions for Use (IFU).
The participant must have a patent jugular vein or subclavian vein.

Exclusion Criteria

The participant has known central venous stenosis
Based on the local primary investigator's discretion, the patient would not be an appropriate study candidate.
The participant has already undergone an AVF or AVG procedure and is awaiting maturation.
The participant has an active infection at the time of study enrollment.
The participant has a presence of bacteremia or infection within 7 days prior to enrollment.
The participant has a history neutropenia or a history of severe immunodeficiency disease.
The participant has uncontrolled abnormal coagulation parameters and are at additional risk for clotting or excessive bleeding at time of enrollment per physicians opinion.
The participant has a known allergy, intolerance or sensitivity to heparin, or previous incidence of heparin-induced thrombocytopenia.
The participant has a known allergy or hypersensitivity to any of the device materials or Ethylene oxide (EtO).
The participant has another medical condition or treatment, which in the opinion of the investigator, the participant may be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for completion of study procedures and follow-up.
The participant is currently participating in an investigational drug or another device study that has not completed the study treatment or that clinically interferes with the study endpoints. Note: Studies requiring extended follow-up visits for products that were investigational but have since become commercially available, are not considered investigational studies.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pristine™ Long-Term Hemodialysis Catheter	Pristine™ Long-Term Hemodialysis Catheter	The Pristine™ Long-Term Hemodialysis Catheter is a chronic hemodialysis catheter consisting of a dual lumen radiopaque shaft with a pre-formed split tip, which enables long-term vascular access for hemodialysis. The device is intended to be used in patients suffering from chronic kidney disease. The Pristine™ Catheter will be placed according to the Instructions for Use (IFU).

Primary Outcome Measures

Name	Time	Method
Overall Complication Rate of the Pristine™ Catheter	At 3 months post index procedure.	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.

Secondary Outcome Measures

Name	Time	Method
Rate of Technical Success	At time of Index Procedure.	Number of Participants with successful placement of the Pristine™ Long-Term Hemodialysis Catheter
Rate of Freedom From Catheter-related Bloodstream Infection (CRBSI)	1-month Post-Index Procedure.	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.
Rate of Freedom From Device and/or Procedure-related Adverse Events	1-month Post-Index Procedure.	Number of participants free from Device and/or Procedure-related adverse events.
Overall Participant Survival Rate	1-month Post-Index Procedure.	Number of participants that have not died from any catheter related complication.
Overall Catheter Survival Rate	1-month Post-Index Procedure	Number of participants with whom the Pristine™ Catheters have not been removed for any cause.
Overall Patency Rate	1-month Post-Index Procedure	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.

Trial Locations

Locations (6): Trinity Research Group LLC
🇺🇸
Dothan, Alabama, United States
North Carolina Nephrology, PA
🇺🇸
Raleigh, North Carolina, United States
Louisiana State University Health Shreveport Medical Center
🇺🇸
Shreveport, Louisiana, United States
Henry Ford Health System
🇺🇸
Detroit, Michigan, United States
JML Research Associates
🇺🇸
Providence, Rhode Island, United States
Yale University
🇺🇸
New Haven, Connecticut, United States