The Pristine Post-Market Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Overall Complication Rate of the Pristine™ Catheter [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 Outcome Measures
- Rate of freedom from catheter-related bloodstream infection (CRBSI) [At 1-month, 3-months, 6-months, and 12 months post-index procedure.]
Defined by 2019 KDOQI Guidelines for CRBSI.
- Rate of freedom from Device and/or Procedure-related adverse events [At 1-month, 3-months, 6-months, and 12 months post-index procedure.]
- Rate of Technical Success [At 1-month, 3-months, 6-months, and 12 months post-index procedure.]
Defined as the successful placement of the Pristine™ Long-Term Hemodialysis Catheter
- Overall Participant Survival Rate [At 1-month, 3-months, 6-months, and 12 months post-index procedure.]
Defined as the proportion of participants that have not died from any catheter related complication.
- Overall Catheter Survival Rate [At 1-month, 3-months, 6-months, and 12 months post-index procedure.]
Defined as the proportion of Pristine™ Catheters that have not been removed for any cause.
- Overall Patency Rate [At 1-month, 3-months, 6-months, and 12 months post-index procedure.]
Defined as the Pristine™ catheter having the ability to achieve a mean dialysis blood flow of ≥300mL/min without need for additional interventions.
Other Outcome Measures
- Kit Component Safety and Performance [At 1-month, 3-months, 6-months, and 12 months post-index procedure.]
Defined as the overall rate of the catheter's procedure kit component complications from time of procedure to discharge.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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The participant must be willing and able to comply with protocol requirements, including all study visits and procedures.
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The participant must be either a male or non-pregnant female ≥18 years of age.
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The participant must have a diagnosis of End Stage Renal Disease with indication for a tunneled dialysis catheter creation.
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Participant must require chronic hemodialysis treatments 3 times per week with intended use of the Pristine™ Long-Term Hemodialysis Catheter.
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The participant meets the indications for hemodialysis use and does not meet any of the contraindications per the Pristine Instructions for Use (IFU).
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The participant must have a patent jugular vein or subclavian vein.
Exclusion Criteria:
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The participant has known central venous stenosis
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Based on the local primary investigator's discretion, the patient would not be an appropriate study candidate.
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The participant has already undergone an AVF or AVG procedure and is awaiting maturation.
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The participant has an active infection at the time of study enrollment.
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The participant has a presence of bacteremia or infection within 7 days prior to enrollment.
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The participant has a history neutropenia or a history of severe immunodeficiency disease.
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The participant has uncontrolled abnormal coagulation parameters and are at additional risk for clotting or excessive bleeding at time of enrollment per physicians opinion.
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The participant has a known allergy, intolerance or sensitivity to heparin, or previous incidence of heparin-induced thrombocytopenia.
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The participant has a known allergy or hypersensitivity to any of the device materials or Ethylene oxide (EtO).
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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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Trinity Research Group LLC | Dothan | Alabama | United States | 36301 |
| 2 | Yale University | New Haven | Connecticut | United States | 06520 |
| 3 | Louisiana State University Health Shreveport Medical Center | Shreveport | Louisiana | United States | 71103 |
| 4 | Henry Ford Health System | Detroit | Michigan | United States | 48202 |
| 5 | North Carolina Nephrology, PA | Raleigh | North Carolina | United States | 27610 |
| 6 | JML Research Associates | Providence | Rhode Island | United States | 02906 |
Sponsors and Collaborators
- C. R. Bard
Investigators
- Principal Investigator: Jeffrey Hoggard, MD, Raleigh Access Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BDPI-21-001