The Pristine Post-Market Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Multi-Center, Single-Arm Clinical Study of the Pristine™ Long-Term Hemodialysis Catheter

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

Intervention / Treatment
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* Device: Pristine™ Long-Term Hemodialysis Catheter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pristine™ Long-Term Hemodialysis Catheter<br>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). | Device: Pristine™ Long-Term Hemodialysis Catheter<br>* Placement of the Pristine™ Long-Term Hemodialysis Catheter Placement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 3 months post index procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of freedom from catheter-related bloodstream infection (CRBSI) | Defined by 2019 KDOQI Guidelines for CRBSI. | At 1-month, 3-months, 6-months, and 12 months post-index procedure. | 
| Rate of freedom from Device and/or Procedure-related adverse events |  | At 1-month, 3-months, 6-months, and 12 months post-index procedure. | 
| Rate of Technical Success | Defined as the successful placement of the Pristine™ Long-Term Hemodialysis Catheter | At 1-month, 3-months, 6-months, and 12 months post-index procedure. | 
| Overall Participant Survival Rate | Defined as the proportion of participants that have not died from any catheter related complication. | At 1-month, 3-months, 6-months, and 12 months post-index procedure. | 
| Overall Catheter Survival Rate | Defined as the proportion of Pristine™ Catheters that have not been removed for any cause. | At 1-month, 3-months, 6-months, and 12 months post-index procedure. | 
| Overall Patency Rate | Defined as the Pristine™ catheter having the ability to achieve a mean dialysis blood flow of ≥300mL/min without need for additional interventions. | At 1-month, 3-months, 6-months, and 12 months post-index procedure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney Replacement Therapy, Hemodialysis, Vascular Access