The Pristine Post-Market Study

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05228132
• Other study ID #: BDPI-21-001
• Status: Terminated
• Phase: N/A
• Start date: May 16, 2022
• Est. completion date: September 21, 2022

Study information

• Verified date: March 2024
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 142
• Est. completion date: September 21, 2022
• Est. primary completion date: September 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Central Venous Catheter Related Bloodstream Infection
• Communicable Diseases
• End Stage Renal Disease
• Hemodialysis Access Failure
• Hemodialysis Catheter Infection
• Hemodialysis Complication
• Infections
• Kidney Failure, Chronic
• Renal Insufficiency
• Sepsis

Intervention

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

Locations

Country	Name	City	State
United States	Henry Ford Health System	Detroit	Michigan
United States	Trinity Research Group LLC	Dothan	Alabama
United States	Yale University	New Haven	Connecticut
United States	JML Research Associates	Providence	Rhode Island
United States	North Carolina Nephrology, PA	Raleigh	North Carolina
United States	Louisiana State University Health Shreveport Medical Center	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome

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