An interventional study of everlinQ endoAVF System in Chronic Kidney Diseases, sponsored by C. R. Bard. Completed at 1 site in Paraguay. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-11.
Sponsored by C. R. Bard (part of Becton, Dickinson and Company) · Not applicable, Interventional, and Treatment
Prospective, single-center study to evaluate the everlinQ endoAVF System when used to create an endoAVF in hemodialysis patients. This study aims to investigate expansion of the percutaneous venous access location to the superficial system which may provide additional procedural benefit.
A total of up to 50 subjects will be enrolled and will undergo an endoAVF creation procedure using the everlinQ System. All subjects may be followed for up to 12 months post index procedure based on Investigator's discretion. The duration of the study is expected to be approximately two (2) years.
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
This study's enrollment of 24 is below the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →C. R. Bard is the lead sponsor of 117 studies on the registry; 6 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 13 (76%) have results posted.
First submitted after C. R. Bard became part of Becton, Dickinson and Company.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: everlinQ endoAVF System
The everlinQ device is a single-use disposable device. The everlinQ catheter system consists of two flexible, magnetic catheters. Once the catheters are properly inserted and aligned, the magnets contained in each catheter attract to one another, approximating the vessels while simultaneously aligning the electrode with the backstop. Radiofrequency (RF) energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created.
Number of Participants With Procedural Success
Procedure Success was defined as successful endoAVF creation confirmed via intraprocedural angiography/fistulogram or duplex ultrasound verification performed post procedure.
Time frame: At time of procedure
Adverse Event Rate
Percentage of patients who experience one or more adverse events during the first 3 months following successful endoAVF creation. Adverse events were site-reported and reviewed by an independent Medical Monitor and the Clinical Events Committee (CEC).
Time frame: 3 months following endoAVF creation
Percentage of Participants With Primary Patency at 6 Months Post Index Procedure
Primary Patency was defined as the time interval between the endoAVF index procedure and the earlier of a) any intervention designed to maintain or reestablish patency, b) access thrombosis, or c) access abandonment. Kaplan-Meier (KM) was used to analyze the data.
Time frame: 6 months post index procedure
Number of Participants With EndoAVF Maturation at 1, 3, and 6 Months Post Index Procedure
Maturity of the endoAVF was defined by duplex ultrasound criteria, as described in the literature as a useful surrogate of suitability for dialysis. Maturation was defined as duplex ultrasound flow in the brachial artery of at least 500 ml/min and a vein diameter ≥ 4mm, without significant stenosis or thrombosis. If a subject was on hemodialysis, maturity was defined by successful dialysis with 2-needles at least once.
Time frame: 1, 3, and 6 months post index procedure
Time to Cannulation (Months)
The interval of time from the index procedure to successful 2-needle cannulation of the endoAVF.
Time frame: Months from index procedure to cannulation
Number of Participants With Cannulation Success at Defined Follow-up Intervals
A subject was referred to as a 'cannulation success' with the first successful 2-needle cannulation of the endoAVF access circuit. "Cannulation Success" was defined by at least one successful hemodialysis session through a 2-needle cannulation of the endoAVF access circuit. "Cumulative Cannulation Success" = (Successes Through End Current Interval) / (Subjects on Dialysis at Start Current Interval + Censored Dialysis Subjects through End of Last Interval).
Time frame: 0-10 days, 11-45 days, 46-135 days, 136-210 days post index procedure
Percentage of Participants With Assisted Primary Patency at 6 Months
Defined as the interval from access placement to thrombosis or abandonment; not triggered by access circuit interventions performed in the absence of occlusion.
Time frame: 6 months post index procedure
Percentage of Participants With Secondary Patency at 6 Months Post Index Procedure
Secondary Patency was defined as the time interval between the endoAVF index procedure and a) access abandonment, or b) loss to thrombosis, irrespective of intervening surgical or endovascular interventions designed to re-establish functionality in a stenosed or thrombosed access circuit.
Time frame: 6 months post index procedure
Percentage of Participants With Functional Patency of the endoAVF at 6 Months Post Index Procedure
The interval of time from the first 2-needle dialysis utilizing the access until access abandonment (SVS Reporting Standards definition). Functional Patency was the interval of time from the first 2-needle dialysis of the endoAVF access circuit until access abandonment.
Time frame: 6 months post index procedure
Number of Participants With EndoAVF Related Reintervention
The re-intervention rate for endoAVF (defined as any intervention required to maintain or re-establish patency) was calculated at each available follow-up visit post index procedure.
Time frame: At 6 months follow-up
Percentage of Participants With Modified Primary Patency at 6 Months Post Index Procedure
Modified Primary Patency was defined as a measure of patency that, in addition to occlusion or reinterventions within the access circuit, also included coil embolization or open surgical ligation of outflow venous branches as failures of patency when they occur after the index procedure.
Time frame: 6 months post index procedure
The EverlinQ Endovascular Access Systems Enhancements (EASE-2) study began enrollment on October 5th 2017 and the last patient was enrolled on May 23rd 2018.
| Milestone | endoAVF |
|---|---|
| Started | 24 |
| Completed | 12 |
| Not completed | 12 |
Procedure Success was defined as successful endoAVF creation confirmed via intraprocedural angiography/fistulogram or duplex ultrasound verification performed post procedure.
| Participants | endoAVF |
|---|---|
| Number of Participants With Procedural Success | 19 |
Percentage of patients who experience one or more adverse events during the first 3 months following successful endoAVF creation. Adverse events were site-reported and reviewed by an independent Medical Monitor and the Clinical Events Committee (CEC).
| Participants | endoAVF |
|---|---|
| Adverse Event Rate | 4 |
Primary Patency was defined as the time interval between the endoAVF index procedure and the earlier of a) any intervention designed to maintain or reestablish patency, b) access thrombosis, or c) access abandonment. Kaplan-Meier (KM) was used to analyze the data.
| Percentage of participants | endoAVF |
|---|---|
| Percentage of Participants With Primary Patency at 6 Months Post Index Procedure | 70.8 |
Maturity of the endoAVF was defined by duplex ultrasound criteria, as described in the literature as a useful surrogate of suitability for dialysis. Maturation was defined as duplex ultrasound flow in the brachial artery of at least 500 ml/min and a vein diameter ≥ 4mm, without significant stenosis or thrombosis. If a subject was on hemodialysis, maturity was defined by successful dialysis with 2-needles at least once.
| Participants | endoAVF |
|---|---|
| 1 month post index procedure | 19 |
| 3 months post index procedure | 20 |
| 6 months post index procedure | 20 |
The interval of time from the index procedure to successful 2-needle cannulation of the endoAVF.
| Months | endoAVF |
|---|---|
| Time to Cannulation (Months) | 1.2 ± 0.3 |
A subject was referred to as a 'cannulation success' with the first successful 2-needle cannulation of the endoAVF access circuit. "Cannulation Success" was defined by at least one successful hemodialysis session through a 2-needle cannulation of the endoAVF access circuit. "Cumulative Cannulation Success" = (Successes Through End Current Interval) / (Subjects on Dialysis at Start Current Interval + Censored Dialysis Subjects through End of Last Interval).
| Participants | endoAVF |
|---|---|
| 0 to 10 days post index procedure | 0 |
| 11 to 45 days post index procedure | 11 |
| 46-135 days post index procedure | 13 |
| 136-210 days post index procedure | 13 |
Defined as the interval from access placement to thrombosis or abandonment; not triggered by access circuit interventions performed in the absence of occlusion.
| Percentage of Participants | endoAVF |
|---|---|
| Percentage of Participants With Assisted Primary Patency at 6 Months | 70.8 |
Secondary Patency was defined as the time interval between the endoAVF index procedure and a) access abandonment, or b) loss to thrombosis, irrespective of intervening surgical or endovascular interventions designed to re-establish functionality in a stenosed or thrombosed access circuit.
| Percentage of participants | endoAVF |
|---|---|
| Percentage of Participants With Secondary Patency at 6 Months Post Index Procedure | 70.8 |
The interval of time from the first 2-needle dialysis utilizing the access until access abandonment (SVS Reporting Standards definition). Functional Patency was the interval of time from the first 2-needle dialysis of the endoAVF access circuit until access abandonment.
| Percentage of participants | endoAVF |
|---|---|
| Percentage of Participants With Functional Patency of the endoAVF at 6 Months Post Index Procedure | 90.9 (50.8 to 98.7) |
The re-intervention rate for endoAVF (defined as any intervention required to maintain or re-establish patency) was calculated at each available follow-up visit post index procedure.
| Participants | endoAVF |
|---|---|
| Number of Participants With EndoAVF Related Reintervention | 3 |
Modified Primary Patency was defined as a measure of patency that, in addition to occlusion or reinterventions within the access circuit, also included coil embolization or open surgical ligation of outflow venous branches as failures of patency when they occur after the index procedure.
| Percentage of participants | endoAVF |
|---|---|
| Percentage of Participants With Modified Primary Patency at 6 Months Post Index Procedure | 70.8 |
Collected over Serious Adverse Events (SAEs) were collected through 6-months post-index procedure.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| endoAVF | 2/24 (8.3%) | 4/24 (16.7%) | 6/24 (25%) |
| Event | endoAVF |
|---|---|
| ThrombosisVascular disorders | 2/24 |
| PseudoanurysmVascular disorders | 1/24 |
| InfectionInfections and infestations | 1/24 |
| Event | endoAVF |
|---|---|
| Pseudo-aneurysmVascular disorders | 2/24 |
| ThrombosisVascular disorders | 2/24 |
| OcclusionVascular disorders | 1/24 |
| SwellingSkin and subcutaneous tissue disorders | 1/24 |
| Age, Continuous(Years) | endoAVF |
|---|---|
| Mean | 49.0 ± 11.1 |
| Sex: Female, Male(Participants) | endoAVF |
|---|---|
| Female | 6 |
| Male | 18 |
| Ethnicity (NIH/OMB)(Participants) | endoAVF |
|---|---|
| Hispanic or Latino | 24 |
| Not Hispanic or Latino | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | endoAVF |
|---|---|
| Paraguay | 24 |
| Access Artery(Participants) | endoAVF |
|---|---|
| Brachial | 2 |
| Ulnar | 16 |
| Radial | 6 |
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Renal Insufficiency, Chronic →