Kidney Failure, ChronicNCT05228132

The Pristine Post-Market Study

A study testing Pristine™ Long-Term Hemodialysis Catheter in people with Kidney Failure, Chronic and Hemodialysis Complication, run by C. R. Bard at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Kidney Failure, Chronic, Hemodialysis Complication, Hemodialysis Catheter Infection
What is being tested?: Pristine™ Long-Term Hemodialysis Catheter
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 142 participants
Where: 6 sitesUnited States
Study dates: 16 May 2022to 21 Sep 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.
The participant must be willing and able to comply with protocol requirements, including all study visits and procedures.
The participant must be either a male or non-pregnant female ≥18 years of age.
The participant must have a diagnosis of End Stage Renal Disease with indication for a tunneled dialysis catheter creation.
Participant must require chronic hemodialysis treatments 3 times per week with intended use of the Pristine™ Long-Term Hemodialysis Catheter.
The participant meets the indications for hemodialysis use and does not meet any of the contraindications per the Pristine Instructions for Use (IFU).
The participant must have a patent jugular vein or subclavian vein.

Who cannot join

The participant has known central venous stenosis
Based on the local primary investigator's discretion, the patient would not be an appropriate study candidate.
The participant has already undergone an AVF or AVG procedure and is awaiting maturation.
The participant has an active infection at the time of study enrollment.
The participant has a presence of bacteremia or infection within 7 days prior to enrollment.
The participant has a history neutropenia or a history of severe immunodeficiency disease.

Show all 11Show fewer

The participant has uncontrolled abnormal coagulation parameters and are at additional risk for clotting or excessive bleeding at time of enrollment per physicians opinion.
The participant has a known allergy, intolerance or sensitivity to heparin, or previous incidence of heparin-induced thrombocytopenia.
The participant has a known allergy or hypersensitivity to any of the device materials or Ethylene oxide (EtO).
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.
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.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Henry Ford Health System
Detroit, Michigan, 48202
Trinity Research Group LLC
Dothan, Alabama, 36301
Yale University
New Haven, Connecticut, 06520
JML Research Associates
Providence, Rhode Island, 02906
North Carolina Nephrology, PA
Raleigh, North Carolina, 27610
Louisiana State University Health Shreveport Medical Center
Shreveport, Louisiana, 71103

Other trials in United States

About this study

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

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

Read the 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.

Conditions: Kidney Failure, Chronic, Hemodialysis Complication, Hemodialysis Catheter Infection, Hemodialysis Access Failure, Central Venous Catheter Related Bloodstream Infection, End Stage Renal Disease
Being tested: Pristine™ Long-Term Hemodialysis Catheter
Keywords: Kidney Replacement Therapy, Hemodialysis, Vascular Access
Medical subject headings: Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05228132
Study group	Role	What they receive
Pristine™ Long-Term Hemodialysis Catheter	Experimental	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). Receives: Device: Pristine™ Long-Term Hemodialysis Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: At 3 months post index procedure.

Secondary outcomes (6)

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.
Measured: 1-month Post-Index Procedure.
Rate of Freedom From Device and/or Procedure-related Adverse Events
Number of participants free from Device and/or Procedure-related adverse events.
Measured: 1-month Post-Index Procedure.
Rate of Technical Success
Number of Participants with successful placement of the Pristine™ Long-Term Hemodialysis Catheter
Measured: At time of Index Procedure.
Overall Participant Survival Rate
Number of participants that have not died from any catheter related complication.
Measured: 1-month Post-Index Procedure.
Overall Catheter Survival Rate
Number of participants with whom the Pristine™ Catheters have not been removed for any cause.
Measured: 1-month Post-Index Procedure
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.
Measured: 1-month Post-Index Procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 May 202221 Sep 2022

First posted8 Feb 2022
Study start16 May 2022
Primary completion21 Sep 2022
Study completion21 Sep 2022

Why it stopped: Terminated due to considerable changes in the clinical landscape post Covid-19, leading to difficulties executing the study. Results were blinded at time of termination.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 142 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05228132
Sponsor's protocol ID: BDPI-21-001
Status last verified: Mar 2024
First submitted: 27 Jan 2022
Last updated: 11 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Kidney Failure, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi-Center, Single-Arm Clinical Study of the Pristine™ Long-Term Hemodialysis Catheter
ClinicalTrials.gov ID: NCT05228132
Acronym / sponsor ID: BDPI-21-001
Conditions: Kidney Failure, Chronic, Hemodialysis Complication, Hemodialysis Catheter Infection, Hemodialysis Access Failure, Central Venous Catheter Related Bloodstream Infection, End Stage Renal Disease
Keywords: Kidney Replacement Therapy, Hemodialysis, Vascular Access
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated due to considerable changes in the clinical landscape post Covid-19, leading to difficulties executing the study. Results were blinded at time of termination.
Enrolment: 142 participants (actual)
Lead sponsor: C. R. BardIndustry (pharma, biotech, devices)
Study start: 16 May 2022 (actual)
Primary completion: 21 Sep 2022 (actual)
Study completion: 21 Sep 2022 (actual)
First posted: 8 Feb 2022 (actual)
Results: Posted 11 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Pristine™ Long-Term Hemodialysis Catheter	Experimental	Device: Pristine™ Long-Term Hemodialysis CatheterThe 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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.
The participant must be willing and able to comply with protocol requirements, including all study visits and procedures.
The participant must be either a male or non-pregnant female ≥18 years of age.
The participant must have a diagnosis of End Stage Renal Disease with indication for a tunneled dialysis catheter creation.
Participant must require chronic hemodialysis treatments 3 times per week with intended use of the Pristine™ Long-Term Hemodialysis Catheter.

Key exclusion criteria (11 listed)

The participant has known central venous stenosis
Based on the local primary investigator's discretion, the patient would not be an appropriate study candidate.
The participant has already undergone an AVF or AVG procedure and is awaiting maturation.
The participant has an active infection at the time of study enrollment.
The participant has a presence of bacteremia or infection within 7 days prior to enrollment.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pristine™ Long-Term Hemodialysis CatheterPlacement of the Pristine™ Long-Term Hemodialysis Catheter Placement.	Device	Pristine™ Long-Term Hemodialysis Catheter

Primary outcome

Overall Complication Rate of the Pristine™ Catheter
Time frame: 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.

6 secondary outcomes

Rate of Freedom From Catheter-related Bloodstream Infection (CRBSI)
Time frame: 1-month Post-Index Procedure.
Rate of Freedom From Device and/or Procedure-related Adverse Events
Time frame: 1-month Post-Index Procedure.
Rate of Technical Success
Time frame: At time of Index Procedure.
Overall Participant Survival Rate
Time frame: 1-month Post-Index Procedure.
Overall Catheter Survival Rate
Time frame: 1-month Post-Index Procedure
Overall Patency Rate
Time frame: 1-month Post-Index Procedure

Results and safety

Results posted to the registry on 11 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pristine™ Long-Term Hemodialysis Catheter	7	0

Primary outcome: Overall Complication Rate of the Pristine™ Catheter

Time frame: At 3 months post index procedure.

Population analysed: 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.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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 reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pristine™ Long-Term Hemodialysis Catheter	3 of 7 (42.9%)	2 of 7 (28.6%)	0 of 7

Limitations and caveats (from the sponsor): Early termination was due to considerable changes in the clinical landscape post Covid-19, leading to difficulties executing the study. Results were not source verified nor study data analyzed prior to termination. Given the sample size no analysis was performed on the limited data available.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Kidney Failure, Chronic

Recruiting
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
End Stage Renal Disease
RecruitingObservational study
A Natural History Study of Metabolic Sizing in Health and Disease
Metabolic Disorders, Cancer
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeffrey Hoggard, MD principal investigator

Raleigh Access Center

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Pristine™ Long-Term Hemodialysis Catheter in people with Kidney Failure, Chronic and Hemodialysis Complication, run by C. R. Bard at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Complication Rate of the Pristine™ Catheter (time frame: At 3 months post index procedure.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05228132.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.