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

C. R. Bard6 sites in 1 country142 target enrollmentMay 16, 2022

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

Overview

Phase: N/A
Intervention: Not specified
Conditions: Kidney Failure, Chronic
Sponsor: C. R. Bard
Enrollment: 142
Locations: 6
Primary Endpoint: Overall Complication Rate of the Pristine™ Catheter
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 16, 2022

End Date

September 21, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

C. R. Bard

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Overall Complication Rate of the Pristine™ Catheter

Time Frame: 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 Outcomes

Rate of Technical Success(At time of Index Procedure.)
Rate of Freedom From Catheter-related Bloodstream Infection (CRBSI)(1-month Post-Index Procedure.)
Rate of Freedom From Device and/or Procedure-related Adverse Events(1-month Post-Index Procedure.)
Overall Participant Survival Rate(1-month Post-Index Procedure.)
Overall Catheter Survival Rate(1-month Post-Index Procedure)
Overall Patency Rate(1-month Post-Index Procedure)