everlinQ Endovascular Access Systems Enhancements (EASE-2) Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03708562

Enrollment

Registered

2018-10-17

Start date

2017-10-16

Completion date

2018-12-12

Last updated

2025-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases

Brief 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.

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.

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Procedural Success	At time of procedure	Procedure Success was defined as successful endoAVF creation confirmed via intraprocedural angiography/fistulogram or duplex ultrasound verification performed post procedure.
Adverse Event Rate	3 months following endoAVF creation	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).

Secondary

Measure	Time frame	Description
Time to Cannulation (Months)	Months from index procedure to cannulation	The interval of time from the index procedure to successful 2-needle cannulation of the endoAVF.
Number of Participants With Cannulation Success at Defined Follow-up Intervals	0-10 days, 11-45 days, 46-135 days, 136-210 days post index procedure	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).
Percentage of Participants With Assisted Primary Patency at 6 Months	6 months post index procedure	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 With Primary Patency at 6 Months Post Index Procedure	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.
Percentage of Participants With Functional Patency of the endoAVF at 6 Months Post Index Procedure	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.
Number of Participants With EndoAVF Related Reintervention	At 6 months follow-up	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.
Percentage of Participants With Modified Primary Patency at 6 Months Post Index Procedure	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.
Percentage of Participants With Secondary Patency at 6 Months Post Index Procedure	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.
Number of Participants With EndoAVF Maturation at 1, 3, and 6 Months Post Index Procedure	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.

Countries

Paraguay

Participant flow

Recruitment details

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.

Participants by arm

Arm	Count
endoAVF 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. RF energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created.	24
Total	24

Arm

Count

endoAVF

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. RF energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created.

Total

Baseline characteristics

Characteristic	endoAVF
Access Artery Brachial	2 Participants
Access Artery Radial	6 Participants
Access Artery Ulnar	16 Participants
Age, Continuous	49.0 Years STANDARD_DEVIATION 11.1
Ethnicity (NIH/OMB) Hispanic or Latino	24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Region of Enrollment Paraguay	24 participants
Sex: Female, Male Female	6 Participants
Sex: Female, Male Male	18 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	2 / 24
other Total, other adverse events	6 / 24
serious Total, serious adverse events	4 / 24

Outcome results

Primary

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
endoAVF	Adverse Event Rate	4 Participants

Primary

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
endoAVF	Number of Participants With Procedural Success	19 Participants

Secondary

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

Population: Overall number of participants analyzed (n), and participants analyzed for each follow-up period varies from total participants in the study (N=24) according to the number of participants that attend follow-up and/or had data relevant to the analysis.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
endoAVF	Number of Participants With Cannulation Success at Defined Follow-up Intervals	0 to 10 days post index procedure	0 Participants
endoAVF	Number of Participants With Cannulation Success at Defined Follow-up Intervals	11 to 45 days post index procedure	11 Participants
endoAVF	Number of Participants With Cannulation Success at Defined Follow-up Intervals	46-135 days post index procedure	13 Participants
endoAVF	Number of Participants With Cannulation Success at Defined Follow-up Intervals	136-210 days post index procedure	13 Participants

Secondary

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
endoAVF	Number of Participants With EndoAVF Maturation at 1, 3, and 6 Months Post Index Procedure	1 month post index procedure	19 Participants
endoAVF	Number of Participants With EndoAVF Maturation at 1, 3, and 6 Months Post Index Procedure	3 months post index procedure	20 Participants
endoAVF	Number of Participants With EndoAVF Maturation at 1, 3, and 6 Months Post Index Procedure	6 months post index procedure	20 Participants

Secondary

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
endoAVF	Number of Participants With EndoAVF Related Reintervention	3 Participants

Secondary

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.