The Pristine Post-Market Study

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

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

Study Overview

• Status: Terminated
• Conditions: End Stage Renal Disease; Kidney Failure, Chronic; Hemodialysis Access Failure; Hemodialysis Complication; Central Venous Catheter Related Bloodstream Infection; Hemodialysis Catheter Infection
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States, 36301
      • Trinity Research Group LLC
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • Louisiana State University Health Shreveport Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • North Carolina
    • Raleigh, North Carolina, United States, 27610
      • North Carolina Nephrology, PA
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • JML Research Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. The participant must be willing and able to comply with protocol requirements, including all study visits and procedures.
3. The participant must be either a male or non-pregnant female ≥18 years of age.
4. The participant must have a diagnosis of End Stage Renal Disease with indication for a tunneled dialysis catheter creation.
5. Participant must require chronic hemodialysis treatments 3 times per week with intended use of the Pristine™ Long-Term Hemodialysis Catheter.
6. The participant meets the indications for hemodialysis use and does not meet any of the contraindications per the Pristine Instructions for Use (IFU).
7. The participant must have a patent jugular vein or subclavian vein.

Exclusion Criteria:

1. The participant has known central venous stenosis
2. Based on the local primary investigator's discretion, the patient would not be an appropriate study candidate.
3. The participant has already undergone an AVF or AVG procedure and is awaiting maturation.
4. The participant has an active infection at the time of study enrollment.
5. The participant has a presence of bacteremia or infection within 7 days prior to enrollment.
6. The participant has a history neutropenia or a history of severe immunodeficiency disease.
7. The participant has uncontrolled abnormal coagulation parameters and are at additional risk for clotting or excessive bleeding at time of enrollment per physicians opinion.
8. The participant has a known allergy, intolerance or sensitivity to heparin, or previous incidence of heparin-induced thrombocytopenia.
9. The participant has a known allergy or hypersensitivity to any of the device materials or Ethylene oxide (EtO).
10. 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.
11. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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).

Device: Pristine™ Long-Term Hemodialysis Catheter; Placement of the Pristine™ Long-Term Hemodialysis Catheter Placement.

What is the study measuring?

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)	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.	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.	1-month Post-Index Procedure.
Rate of Technical Success	Number of Participants with successful placement of the Pristine™ Long-Term Hemodialysis Catheter	At time of Index Procedure.
Overall Participant Survival Rate	Number of participants that have not died from any catheter related complication.	1-month Post-Index Procedure.
Overall Catheter Survival Rate	Number of participants with whom the Pristine™ Catheters have not been removed for any cause.	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.	1-month Post-Index Procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kit Component Safety and Performance	Defined as the overall rate of the catheter's procedure kit component complications from time of procedure to discharge.	From Index Procedure to Discharge, of which every participant was same day procedure to discharge.

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: Jeffrey Hoggard, MD, Raleigh Access Center

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2022
• Primary Completion (Actual): September 21, 2022
• Study Completion (Actual): September 21, 2022

Study Registration Dates

• First Submitted: January 27, 2022
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Hemodialysis; Vascular Access; Kidney Replacement Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Sepsis; Infections; Communicable Diseases; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: BDPI-21-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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.: No