The Pristine Post-Market Study

NCT05228132 | Terminated Results DMC FDA Device

• 1 other identifier: BDPI-21-001
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 6

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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.

• Rate of Technical Success

  At time of Index Procedure.

• Overall Participant Survival Rate

  1-month Post-Index Procedure.

• Overall Catheter Survival Rate

  1-month Post-Index Procedure

Other Outcomes (1)

• Kit Component Safety and Performance

  From Index Procedure to Discharge, of which every participant was same day procedure to discharge.

Study Arms (1)

Pristine™ Long-Term Hemodialysis Catheter

EXPERIMENTAL

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

Interventions

Pristine™ Long-Term Hemodialysis Catheter DEVICE

Placement of the Pristine™ Long-Term Hemodialysis Catheter Placement.

Pristine™ Long-Term Hemodialysis Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (6)

Trinity Research Group LLC

Dothan, Alabama, 36301, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Louisiana State University Health Shreveport Medical Center

Shreveport, Louisiana, 71103, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

North Carolina Nephrology, PA

Raleigh, North Carolina, 27610, United States

Location

JML Research Associates

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Early termination was due to considerable changes in the clinical landscape post Covid-19, leading to difficulties executing the study. Results were not source verified nor study data analyzed prior to termination. Given the sample size no analysis was performed on the limited data available.

Results Point of Contact

• Title: Joshua Black, Clinical Project Manager
• Organization: Becton Dickinson

joshua.black@bd.com

520-599-6124

Study Officials

• Jeffrey Hoggard, MD

  Raleigh Access Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 8, 2022
• Study Start: May 16, 2022
• Primary Completion: September 21, 2022
• Study Completion: September 21, 2022
• Last Updated: April 11, 2024
• Results First Posted: April 11, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)