Trial Outcomes & Findings for everlinQ Endovascular Access Systems Enhancements (EASE-2) Study (NCT NCT03708562)

Results Overview

Procedure Success was defined as successful endoAVF creation confirmed via intraprocedural angiography/fistulogram or duplex ultrasound verification performed post procedure.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

At time of procedure

Results posted on

2025-12-11

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 milestones

Participant milestones
Measure	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. Radiofrequency (RF) energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created.
Overall Study STARTED	24
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

everlinQ Endovascular Access Systems Enhancements (EASE-2) Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	endoAVF n=24 Participants 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.
Age, Continuous	49.0 Years STANDARD_DEVIATION 11.1 • n=237 Participants
Sex: Female, Male Female	6 Participants n=237 Participants
Sex: Female, Male Male	18 Participants n=237 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	24 Participants n=237 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=237 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=237 Participants
Region of Enrollment Paraguay	24 participants n=237 Participants
Access Artery Brachial	2 Participants n=237 Participants
Access Artery Ulnar	16 Participants n=237 Participants
Access Artery Radial	6 Participants n=237 Participants

PRIMARY outcome

Timeframe: At time of procedure

Procedure Success was defined as successful endoAVF creation confirmed via intraprocedural angiography/fistulogram or duplex ultrasound verification performed post procedure.

Outcome measures

Outcome measures
Measure	endoAVF n=24 Participants 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	19 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	endoAVF n=24 Participants 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.
Adverse Event Rate	4 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	endoAVF n=24 Participants 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.
Percentage of Participants With Primary Patency at 6 Months Post Index Procedure	70.8 Percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	endoAVF n=24 Participants 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 EndoAVF Maturation at 1, 3, and 6 Months Post Index Procedure 1 month post index procedure	19 Participants
Number of Participants With EndoAVF Maturation at 1, 3, and 6 Months Post Index Procedure 3 months post index procedure	20 Participants
Number of Participants With EndoAVF Maturation at 1, 3, and 6 Months Post Index Procedure 6 months post index procedure	20 Participants

SECONDARY outcome

Timeframe: Months from index procedure to cannulation

Population: Analysis population is lower than total subject number due to subject withdrawals before this endpoint could be analyzed.

The interval of time from the index procedure to successful 2-needle cannulation of the endoAVF.

Outcome measures

Outcome measures
Measure	endoAVF n=13 Participants 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.
Time to Cannulation (Months)	1.2 Months Standard Deviation 0.3

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	endoAVF n=20 Participants 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 Cannulation Success at Defined Follow-up Intervals 0 to 10 days post index procedure	0 Participants
Number of Participants With Cannulation Success at Defined Follow-up Intervals 11 to 45 days post index procedure	11 Participants
Number of Participants With Cannulation Success at Defined Follow-up Intervals 46-135 days post index procedure	13 Participants
Number of Participants With Cannulation Success at Defined Follow-up Intervals 136-210 days post index procedure	13 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	endoAVF n=24 Participants 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.
Percentage of Participants With Assisted Primary Patency at 6 Months	70.8 Percentage of Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	endoAVF n=24 Participants 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.
Percentage of Participants With Secondary Patency at 6 Months Post Index Procedure	70.8 Percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	endoAVF n=24 Participants 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.
Percentage of Participants With Functional Patency of the endoAVF at 6 Months Post Index Procedure	90.9 Percentage of participants Interval 50.8 to 98.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	endoAVF n=24 Participants 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 EndoAVF Related Reintervention	3 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	endoAVF n=24 Participants 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.
Percentage of Participants With Modified Primary Patency at 6 Months Post Index Procedure	70.8 Percentage of participants

Adverse Events

endoAVF

Serious events: 4 serious events

Other events: 6 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	endoAVF n=24 participants at risk 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.
Vascular disorders Thrombosis	8.3% 2/24 • Number of events 2 • Serious Adverse Events (SAEs) were collected through 6-months post-index procedure. Significant Events were classified by the independent Medical Monitor and included device or procedure-related adverse events that either a) could be limb-threatening if not promptly identified or treated, or b) required additional therapy to reestablish patency of the endoAVF access circuit, irrespective of whether they met the criteria for an SAE.
Vascular disorders Pseudoanurysm	4.2% 1/24 • Number of events 1 • Serious Adverse Events (SAEs) were collected through 6-months post-index procedure. Significant Events were classified by the independent Medical Monitor and included device or procedure-related adverse events that either a) could be limb-threatening if not promptly identified or treated, or b) required additional therapy to reestablish patency of the endoAVF access circuit, irrespective of whether they met the criteria for an SAE.
Infections and infestations Infection	4.2% 1/24 • Number of events 1 • Serious Adverse Events (SAEs) were collected through 6-months post-index procedure. Significant Events were classified by the independent Medical Monitor and included device or procedure-related adverse events that either a) could be limb-threatening if not promptly identified or treated, or b) required additional therapy to reestablish patency of the endoAVF access circuit, irrespective of whether they met the criteria for an SAE.

Other adverse events

Other adverse events
Measure	endoAVF n=24 participants at risk 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.
Vascular disorders Pseudo-aneurysm	8.3% 2/24 • Number of events 2 • Serious Adverse Events (SAEs) were collected through 6-months post-index procedure. Significant Events were classified by the independent Medical Monitor and included device or procedure-related adverse events that either a) could be limb-threatening if not promptly identified or treated, or b) required additional therapy to reestablish patency of the endoAVF access circuit, irrespective of whether they met the criteria for an SAE.
Vascular disorders Thrombosis	8.3% 2/24 • Number of events 2 • Serious Adverse Events (SAEs) were collected through 6-months post-index procedure. Significant Events were classified by the independent Medical Monitor and included device or procedure-related adverse events that either a) could be limb-threatening if not promptly identified or treated, or b) required additional therapy to reestablish patency of the endoAVF access circuit, irrespective of whether they met the criteria for an SAE.
Vascular disorders Occlusion	4.2% 1/24 • Number of events 1 • Serious Adverse Events (SAEs) were collected through 6-months post-index procedure. Significant Events were classified by the independent Medical Monitor and included device or procedure-related adverse events that either a) could be limb-threatening if not promptly identified or treated, or b) required additional therapy to reestablish patency of the endoAVF access circuit, irrespective of whether they met the criteria for an SAE.
Skin and subcutaneous tissue disorders Swelling	4.2% 1/24 • Number of events 1 • Serious Adverse Events (SAEs) were collected through 6-months post-index procedure. Significant Events were classified by the independent Medical Monitor and included device or procedure-related adverse events that either a) could be limb-threatening if not promptly identified or treated, or b) required additional therapy to reestablish patency of the endoAVF access circuit, irrespective of whether they met the criteria for an SAE.

Additional Information

Courtney Rothwell

Becton Dickinson (BPV)

Phone: 480-350-6037

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place