Central Venous Catheter Related Bloodstream Infection, End Stage Renal Disease, Hemodialysis Access Failure, Hemodialysis Catheter Infection, Hemodialysis Complication, Kidney Failure, Chronic
Conditions
Keywords
Kidney Replacement Therapy, Hemodialysis, Vascular Access
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.
Interventions
DEVICEPristine™ Long-Term Hemodialysis Catheter
Placement of the Pristine™ Long-Term Hemodialysis Catheter Placement.
Sponsors
C. R. Bard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of Freedom From Catheter-related Bloodstream Infection (CRBSI) | 1-month Post-Index Procedure. | 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. |
| Rate of Freedom From Device and/or Procedure-related Adverse Events | 1-month Post-Index Procedure. | Number of participants free from Device and/or Procedure-related adverse events. |
| Rate of Technical Success | At time of Index Procedure. | Number of Participants with successful placement of the Pristine™ Long-Term Hemodialysis Catheter |
| Overall Catheter Survival Rate | 1-month Post-Index Procedure | Number of participants with whom the Pristine™ Catheters have not been removed for any cause. |
| Overall Patency Rate | 1-month Post-Index Procedure | 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. |
| Overall Participant Survival Rate | 1-month Post-Index Procedure. | Number of participants that have not died from any catheter related complication. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Kit Component Safety and Performance | From Index Procedure to Discharge, of which every participant was same day procedure to discharge. | Defined as the overall rate of the catheter's procedure kit component complications from time of procedure to discharge. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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).
Pristine™ Long-Term Hemodialysis Catheter: Placement of the Pristine™ Long-Term Hemodialysis Catheter Placement. | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Arteriovenous-fistula mature | 1 |
| Overall Study | Investigation Early Termination by Sponsor | 2 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Pristine™ Long-Term Hemodialysis Catheter |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 2 / 7 |
| serious Total, serious adverse events | 3 / 7 |
Outcome results
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.
Time frame: At 3 months post index procedure.
Population: No participants were followed out to the 3-Month follow-up thus the primary endpoint analysis was not performed. With no source verification or analysis performed, there may be inaccurate reporting and potential misrepresentation of the result.
Secondary
Overall Catheter Survival Rate
Number of participants with whom the Pristine™ Catheters have not been removed for any cause.
Time frame: 1-month Post-Index Procedure
Population: No data was collected out to the timepoints following 1-month due to early study termination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pristine™ Long-Term Hemodialysis Catheter | Overall Catheter Survival Rate | 4 Participants |
Secondary
Overall Participant Survival Rate
Number of participants that have not died from any catheter related complication.
Time frame: 1-month Post-Index Procedure.
Population: No data was collected out to the timepoints following 1-month due to early study termination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pristine™ Long-Term Hemodialysis Catheter | Overall Participant Survival Rate | 7 Participants |
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.
Time frame: 1-month Post-Index Procedure
Population: No data was collected out to the timepoints following 1-month due to early study termination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pristine™ Long-Term Hemodialysis Catheter | Overall Patency Rate | 5 Participants |
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.
Time frame: 1-month Post-Index Procedure.
Population: No data was collected out to the timepoints following 1-month due to early study termination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pristine™ Long-Term Hemodialysis Catheter | Rate of Freedom From Catheter-related Bloodstream Infection (CRBSI) | 6 Participants |
Secondary
Rate of Freedom From Device and/or Procedure-related Adverse Events
Number of participants free from Device and/or Procedure-related adverse events.
Time frame: 1-month Post-Index Procedure.
Population: No data was collected out to the timepoints following 1-month due to early study termination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pristine™ Long-Term Hemodialysis Catheter | Rate of Freedom From Device and/or Procedure-related Adverse Events | 4 Participants |
Secondary
Rate of Technical Success
Number of Participants with successful placement of the Pristine™ Long-Term Hemodialysis Catheter
Time frame: At time of Index Procedure.
Population: No data was collected out to the timepoints following 1-month due to early study termination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pristine™ Long-Term Hemodialysis Catheter | Rate of Technical Success | 7 Participants |
Other Pre-specified
Kit Component Safety and Performance
Defined as the overall rate of the catheter's procedure kit component complications from time of procedure to discharge.
Time frame: From Index Procedure to Discharge, of which every participant was same day procedure to discharge.
Population: No data was collected out to the timepoints following 1-month due to early study termination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pristine™ Long-Term Hemodialysis Catheter | Kit Component Safety and Performance | 0 Kit Component Complications |