Clinical trial NCT05228132: The Pristine Post-Market Study
Official title: A Prospective, Multi-Center, Single-Arm Clinical Study of the Pristine™ Long-Term Hemodialysis Catheter
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Kidney Failure, Chronic
Hemodialysis Complication
Hemodialysis Catheter Infection
Hemodialysis Access Failure
Central Venous Catheter Related Bloodstream Infection
End Stage Renal Disease
Keywords: Kidney Replacement Therapy
Hemodialysis
Vascular Access
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2022-02-08
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall Complication Rate of the Pristine™ Catheter
timeFrame: At 3 months post index procedure.
Secondary outcomes:
measure: Rate of Freedom From Catheter-related Bloodstream Infection (CRBSI)
timeFrame: 1-month Post-Index Procedure.
measure: Rate of Freedom From Device and/or Procedure-related Adverse Events
timeFrame: 1-month Post-Index Procedure.
measure: Rate of Technical Success
timeFrame: At time of Index Procedure.
measure: Overall Participant Survival Rate
timeFrame: 1-month Post-Index Procedure.
measure: Overall Catheter Survival Rate
timeFrame: 1-month Post-Index Procedure
measure: Overall Patency Rate
timeFrame: 1-month Post-Index Procedure
Other outcomes:
measure: Kit Component Safety and Performance
timeFrame: From Index Procedure to Discharge, of which every participant was same day procedure to discharge.
Locations:
city: Dothan
country: United States
facility: Trinity Research Group LLC
state: Alabama
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Shreveport
country: United States
facility: Louisiana State University Health Shreveport Medical Center
state: Louisiana
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Raleigh
country: United States
facility: North Carolina Nephrology, PA
state: North Carolina
city: Providence
country: United States
facility: JML Research Associates
state: Rhode Island
Study officials:
affiliation: Raleigh Access Center
name: Jeffrey Hoggard, MD
role: PRINCIPAL_INVESTIGATOR
References: