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CompletedNCT03708562Updated Dec 11, 2025Results posted

everlinQ Endovascular Access Systems Enhancements (EASE-2) Study

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 · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Chronic Kidney Diseases
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Eligible for a native arteriovenous fistula.
  2. Adult (age >18 years old).
  3. Established, non-reversible kidney failure requiring hemodialysis (including pre-dialysis patients).
  4. Target vein diameter(s) at fistula site ≥ 2.0 mm.
  5. Target artery diameter at fistula site ≥ 2.0 mm.
  6. Procedural access site artery and vein diameter ≥ 2.0 mm.
  7. At least one superficial outflow vein diameter ≥ 2.5 mm and in communication with the perforating vein.
  8. Estimated life expectancy > 1 year.
  9. Patient is free of clinically significant conditions or illness within 30 days prior to the AV fistula that may compromise the procedure.
  10. Presence of an antecubital perforating vein diameter ≥ 2.0 mm.

Exclusion criteria

Exclusion Criteria:

  1. Known central venous stenosis or central vein narrowing > 50% based on imaging on the same side as the planned AVF creation.
  2. Upper extremity venous occlusion(s) and/or vessel abnormality(ies) on the same side as the planned AVF creation that precludes endovascular AVF creation by the everlinQ System as deemed by the interventionalists' clinical judgment.
  3. Prior surgically created access in the planned treatment location.
  4. Functioning surgical access in the planned treatment arm.
  5. Pregnant women.
  6. New York Heart Association (NYHA) class III or IV heart failure.
  7. Hypercoagulable state.
  8. Known bleeding diathesis.
  9. Immunosuppression, defined as use of immunosuppressive medications used to treat an active condition.
  10. Documented history of drug abuse including intravenous drugs within six months of AVF creation.
  11. "Planned" concomitant major surgical procedure within 6 months of enrollment or previous major surgery within 30 days of enrollment.
  12. Currently being treated with another investigational device or drug.
  13. Known allergy to contrast dye which cannot be adequately pre-medicated.
  14. Known adverse effects to sedation and/or anesthesia which cannot be adequately pre- medicated.
  15. Patients who do not have an ulnar or radial artery.
  16. Distance between target artery and vein or other anatomical abnormality will not permit catheters to be introduced, navigated to fistula site, or allow magnets to align vessels sufficiently to create the fistula.
  17. Evidence of calcification in vessels at the fistula site.
  18. Evidence of active infections on the day of the index procedure.
  19. Written informed consent not obtained.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Other
    endoAVF

    Device: everlinQ endoAVF System

Interventions

  • DeviceeverlinQ 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.

05

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

06

Results

Posted Jan 2, 2020

Participant flow

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.

Participant flow — Overall Study
MilestoneendoAVF
Started24
Completed12
Not completed12

Outcome measures

PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Procedural Success
ParticipantsendoAVF
Number of Participants With Procedural Success19
PrimaryAdverse 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
Reported as:
Count of participants · Participants
Adverse Event Rate
ParticipantsendoAVF
Adverse Event Rate4
SecondaryPercentage 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
Reported as:
Number · Percentage of participants
Percentage of Participants With Primary Patency at 6 Months Post Index Procedure
Percentage of participantsendoAVF
Percentage of Participants With Primary Patency at 6 Months Post Index Procedure70.8
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With EndoAVF Maturation at 1, 3, and 6 Months Post Index Procedure
ParticipantsendoAVF
1 month post index procedure19
3 months post index procedure20
6 months post index procedure20
SecondaryTime 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
Reported as:
Mean · Months
Time to Cannulation (Months)
MonthsendoAVF
Time to Cannulation (Months)1.2 ± 0.3
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Cannulation Success at Defined Follow-up Intervals
ParticipantsendoAVF
0 to 10 days post index procedure0
11 to 45 days post index procedure11
46-135 days post index procedure13
136-210 days post index procedure13
SecondaryPercentage 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
Reported as:
Number · Percentage of Participants
Percentage of Participants With Assisted Primary Patency at 6 Months
Percentage of ParticipantsendoAVF
Percentage of Participants With Assisted Primary Patency at 6 Months70.8
SecondaryPercentage 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
Reported as:
Number · Percentage of participants
Percentage of Participants With Secondary Patency at 6 Months Post Index Procedure
Percentage of participantsendoAVF
Percentage of Participants With Secondary Patency at 6 Months Post Index Procedure70.8
SecondaryPercentage 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
Reported as:
Number · Percentage of participants
Percentage of Participants With Functional Patency of the endoAVF at 6 Months Post Index Procedure
Percentage of participantsendoAVF
Percentage of Participants With Functional Patency of the endoAVF at 6 Months Post Index Procedure90.9 (50.8 to 98.7)
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With EndoAVF Related Reintervention
ParticipantsendoAVF
Number of Participants With EndoAVF Related Reintervention3
SecondaryPercentage 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
Reported as:
Number · Percentage of participants
Percentage of Participants With Modified Primary Patency at 6 Months Post Index Procedure
Percentage of participantsendoAVF
Percentage of Participants With Modified Primary Patency at 6 Months Post Index Procedure70.8

Adverse events

Collected over Serious Adverse Events (SAEs) were collected through 6-months post-index procedure.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
endoAVF2/24 (8.3%)4/24 (16.7%)6/24 (25%)
Most frequent serious events
Most frequent serious events
EventendoAVF
ThrombosisVascular disorders2/24
PseudoanurysmVascular disorders1/24
InfectionInfections and infestations1/24
Most frequent other events
Most frequent other events
EventendoAVF
Pseudo-aneurysmVascular disorders2/24
ThrombosisVascular disorders2/24
OcclusionVascular disorders1/24
SwellingSkin and subcutaneous tissue disorders1/24

Baseline characteristics

Age, Continuous
Age, Continuous(Years)endoAVF
Mean49.0 ± 11.1
Sex: Female, Male
Sex: Female, Male(Participants)endoAVF
Female6
Male18
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)endoAVF
Hispanic or Latino24
Not Hispanic or Latino0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)endoAVF
Paraguay24
Access Artery
Access Artery(Participants)endoAVF
Brachial2
Ulnar16
Radial6
07

Study locations

1 site
  • Sanatorio Italiano
    Asunción, Paraguay
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Aug 23, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03708562
Lead sponsor
C. R. Bard
Responsible party
Sponsor
First posted
Oct 17, 2018
Start date
Oct 16, 2017
Primary completion
Dec 12, 2018
Completion
Dec 12, 2018
Results posted
Jan 2, 2020
Last update
Dec 11, 2025

Study contacts

Adrian Ebner
principal investigator · Sanatorio Italiano, Paraguay

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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