Trial Outcomes & Findings for The Pristine Post-Market Study (NCT NCT05228132)
NCT ID: NCT05228132
Last Updated: 2024-04-11
Results Overview
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.
TERMINATED
NA
142 participants
At 3 months post index procedure.
2024-04-11
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
1-Month Follow-up
|
2
|
|
Overall Study
3-Month Follow-up
|
0
|
|
Overall Study
6-Month Follow-up
|
0
|
|
Overall Study
12-Month Follow-up
|
0
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
|
Overall Study
Investigation Early Termination by Sponsor
|
2
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Arteriovenous-fistula mature
|
1
|
Baseline Characteristics
The Pristine Post-Market Study
Baseline characteristics by cohort
| Measure |
Pristine™ Long-Term Hemodialysis Catheter
n=7 Participants
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.
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|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1-month Post-Index Procedure.Population: No data was collected out to the timepoints following 1-month due to early study termination.
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.
Outcome measures
| Measure |
Pristine™ Long-Term Hemodialysis Catheter
n=7 Participants
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.
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|---|---|
|
Rate of Freedom From Catheter-related Bloodstream Infection (CRBSI)
|
6 Participants
|
SECONDARY outcome
Timeframe: 1-month Post-Index Procedure.Population: No data was collected out to the timepoints following 1-month due to early study termination.
Number of participants free from Device and/or Procedure-related adverse events.
Outcome measures
| Measure |
Pristine™ Long-Term Hemodialysis Catheter
n=7 Participants
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.
|
|---|---|
|
Rate of Freedom From Device and/or Procedure-related Adverse Events
|
4 Participants
|
SECONDARY outcome
Timeframe: At time of Index Procedure.Population: No data was collected out to the timepoints following 1-month due to early study termination.
Number of Participants with successful placement of the Pristine™ Long-Term Hemodialysis Catheter
Outcome measures
| Measure |
Pristine™ Long-Term Hemodialysis Catheter
n=7 Participants
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.
|
|---|---|
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Rate of Technical Success
|
7 Participants
|
SECONDARY outcome
Timeframe: 1-month Post-Index Procedure.Population: No data was collected out to the timepoints following 1-month due to early study termination.
Number of participants that have not died from any catheter related complication.
Outcome measures
| Measure |
Pristine™ Long-Term Hemodialysis Catheter
n=7 Participants
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.
|
|---|---|
|
Overall Participant Survival Rate
|
7 Participants
|
SECONDARY outcome
Timeframe: 1-month Post-Index ProcedurePopulation: No data was collected out to the timepoints following 1-month due to early study termination.
Number of participants with whom the Pristine™ Catheters have not been removed for any cause.
Outcome measures
| Measure |
Pristine™ Long-Term Hemodialysis Catheter
n=7 Participants
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.
|
|---|---|
|
Overall Catheter Survival Rate
|
4 Participants
|
SECONDARY outcome
Timeframe: 1-month Post-Index ProcedurePopulation: No data was collected out to the timepoints following 1-month due to early study termination.
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.
Outcome measures
| Measure |
Pristine™ Long-Term Hemodialysis Catheter
n=7 Participants
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.
|
|---|---|
|
Overall Patency Rate
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Defined as the overall rate of the catheter's procedure kit component complications from time of procedure to discharge.
Outcome measures
| Measure |
Pristine™ Long-Term Hemodialysis Catheter
n=7 Participants
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.
|
|---|---|
|
Kit Component Safety and Performance
|
0 Kit Component Complications
|
Adverse Events
Pristine™ Long-Term Hemodialysis Catheter
Serious adverse events
| Measure |
Pristine™ Long-Term Hemodialysis Catheter
n=7 participants at risk
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.
|
|---|---|
|
Infections and infestations
Not Device Related-Septic Shock
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Index Procedure to the 1-month Endpoint or until study termination which on average was 42 days, a minimum of 17 days, and a maximum of 77 days.
|
|
Product Issues
Device Related-Thrombosis in device
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Index Procedure to the 1-month Endpoint or until study termination which on average was 42 days, a minimum of 17 days, and a maximum of 77 days.
|
Other adverse events
| Measure |
Pristine™ Long-Term Hemodialysis Catheter
n=7 participants at risk
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.
|
|---|---|
|
Injury, poisoning and procedural complications
Procedural pain
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Index Procedure to the 1-month Endpoint or until study termination which on average was 42 days, a minimum of 17 days, and a maximum of 77 days.
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Index Procedure to the 1-month Endpoint or until study termination which on average was 42 days, a minimum of 17 days, and a maximum of 77 days.
|
Additional Information
Joshua Black, Clinical Project Manager
Becton Dickinson
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place