The Pristine Post-Market Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-16

Study Completion Date

2022-09-21

Brief Summary

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

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Pristine™ Long-Term Hemodialysis Catheter

Intervention Type DEVICE

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

Interventions

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Pristine™ Long-Term Hemodialysis Catheter

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No