Trial Outcomes & Findings for everlinQ Endovascular Access System Enhancements (EASE) Study (NCT NCT03708770)

Last Updated: 2025-12-11

Results Overview

Protocol-defined endoAVF maturation is defined as endoAVF that is free of stenosis or thrombosis, with brachial artery flow at least 500ml/min and at least 4 mm vein diameter (as measured by duplex ultrasound) OR subject was dialized using 2 needles.

Recruitment status

COMPLETED

Study phase

Target enrollment

32 participants

Primary outcome timeframe

Through 6 months post-index procedure

Results posted on

2025-12-11

Participant Flow

First subject enrolled July 27, 2015 and last subject enrolled November 8, 2016. Last subject follow-up was June 19, 2017.

Participant milestones

Participant milestones
Measure	endoAVF everlinQ arteriovenous fistula (endoAVF) System
Overall Study STARTED	32
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

everlinQ Endovascular Access System Enhancements (EASE) Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	endoAVF n=32 Participants everlinQ endoAVF System
Age, Customized Age of Participants	50.9 Years STANDARD_DEVIATION 12.9 • n=237 Participants
Sex: Female, Male Female	1 Participants n=237 Participants
Sex: Female, Male Male	31 Participants n=237 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	32 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	32 participants n=237 Participants
Fistula Type Ulnar-Ulnar	12 Participants n=237 Participants
Fistula Type Radial-Radial	20 Participants n=237 Participants
Access Arm Right	7 Participants n=237 Participants
Access Arm Left	25 Participants n=237 Participants
Access Artery Radial	19 Participants n=237 Participants
Access Artery Brachial	9 Participants n=237 Participants
Access Artery Ulnar	4 Participants n=237 Participants
Access Vein Radial	17 Participants n=237 Participants
Access Vein Brachial	13 Participants n=237 Participants
Access Vein Ulnar	2 Participants n=237 Participants

PRIMARY outcome

Timeframe: Through 6 months post-index procedure

Outcome measures

Outcome measures
Measure	endoAVF n=32 Participants everlinQ arteriovenous fistula (endoAVF) System
Number of Participants With Protocol-Defined endoAVF Maturation	29 Participants

PRIMARY outcome

Timeframe: 3 months following AVF creation

The safety Endpoint is protocol-defined as Device-Related SAE at 3 months.

Outcome measures

Outcome measures
Measure	endoAVF n=32 Participants everlinQ arteriovenous fistula (endoAVF) System
Number of Participants With Device-Related SAEs	0 Participants

SECONDARY outcome

Timeframe: Days from Index Procedure

Defined as the number of days between the date of AVF creation and the date of endoAVF maturation (based on primary efficacy endpoint definition of maturation).

Outcome measures

Outcome measures
Measure	endoAVF n=32 Participants everlinQ arteriovenous fistula (endoAVF) System
Number of Days to Fistula Maturation	9.2 Days from Index Procedure Standard Deviation 19.1

SECONDARY outcome

Timeframe: 6 months post-index procedure

Time from endoAVF creation until access abandonment. Abandonment due to renal transplant receipt was not included in this endpoint assessment.

Outcome measures

Outcome measures
Measure	endoAVF n=32 Participants everlinQ arteriovenous fistula (endoAVF) System
Percentage of Participants With Secondary Patency at 6 Months Post-Index Procedure	86.8 Percentage of participants

SECONDARY outcome

Timeframe: 6 months post-index procedure

Primary Patency is defined as the interval following the index intervention until the next clinically driven reintervention at the original treatment site to maintain or reestablish patency or loss of endoAVF patency. The primary patency rate is determined via Kaplan-Meier methods and based on the time of endoAVF creation until any intervention designed to maintain or reestablish patnecy or endoAVF abandonment.

Outcome measures

Outcome measures
Measure	endoAVF n=32 Participants everlinQ arteriovenous fistula (endoAVF) System
Primary Patency at 6 Months Post-index Procedure	83.3 Percentage of participants

SECONDARY outcome

Timeframe: 1-7 days, 30 days, 3, and 6 months post-index procedure

Population: Number of participants (n) for each follow-up period varies from total participants in the study (N=32) according to the number of participants that attend follow-up and/or had data relevant to the analysis.

Number of participants with Central Venous Catheters (CVC), endoAVF only access, CVC + endoAVF access, and not reciving dialysis at 3 and 6 months post-index procedure.

Outcome measures

Outcome measures
Measure	endoAVF n=32 Participants everlinQ arteriovenous fistula (endoAVF) System
Number of Participants Per Catheter Exposure Type CVC + endoAVF at 6 months post-index	0 Participants
Number of Participants Per Catheter Exposure Type No dialysis at 6 months post-index	0 Participants
Number of Participants Per Catheter Exposure Type CVC only at 1-7 days post index procedure	31 Participants
Number of Participants Per Catheter Exposure Type EndoAVF only at 1-7 days post index procedure	0 Participants
Number of Participants Per Catheter Exposure Type CVC & endoAVF at 1-7 days post index procedure	0 Participants
Number of Participants Per Catheter Exposure Type No dialysis at 1-7 days post-index procedure	1 Participants
Number of Participants Per Catheter Exposure Type CVC only at 30 days post-index procedure	26 Participants
Number of Participants Per Catheter Exposure Type EndoAVF only at 30 days post-index procedure	1 Participants
Number of Participants Per Catheter Exposure Type CVC & endoAVF at 30 days post-index procedure	0 Participants
Number of Participants Per Catheter Exposure Type No dialysis at 30 days post-index procedure	1 Participants
Number of Participants Per Catheter Exposure Type CVC only at 3 months post-index	5 Participants
Number of Participants Per Catheter Exposure Type EndoAVF only 3 months post-index	10 Participants
Number of Participants Per Catheter Exposure Type CVC + endoAVF at 3 months post-index	0 Participants
Number of Participants Per Catheter Exposure Type No dialysis at 3 months post-index	1 Participants
Number of Participants Per Catheter Exposure Type CVC only at 6 months post-index	7 Participants
Number of Participants Per Catheter Exposure Type EndoAVF only 6 months post-index	19 Participants

SECONDARY outcome

Timeframe: 1-7 days following index-procedure

Technical success is defined as verification that an endoAVF has been created and remains patent 1-7 days after the index procedure. Patency is determined by experienced examiner as the presence of a bruit that is detected with stethoscope, or presence of thrill, or via Duplex Ultrasound, or via angiogram.

Outcome measures

Outcome measures
Measure	endoAVF n=32 Participants everlinQ arteriovenous fistula (endoAVF) System
Number of Participants With Technical Success	30 Participants

SECONDARY outcome

Timeframe: At 6 months follow-up

The re-intervention rate for endo-AVF (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=32 Participants everlinQ arteriovenous fistula (endoAVF) System
Number of Endo-AVF-related Re-interventions	2 Participants

Adverse Events

endoAVF

Serious events: 2 serious events

Other events: 7 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	endoAVF n=32 participants at risk everlinQ arteriovenous fistula (endoAVF) System
Blood and lymphatic system disorders Bleeding/Hematoma	3.1% 1/32 • Number of events 1 • Serious Adverse Events (SAEs) were collected through 6-months post-index procedure. Significant Adverse Events are defined as device or procedure-related adverse events (AE) 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 the event was an SAE. The SAE table combines both Significant Events and SAE events. Only AEs relevant to index-procedure, study device, access site or endoAVF were collected and are included in the Other AE table.
Cardiac disorders Heart problems	3.1% 1/32 • Number of events 1 • Serious Adverse Events (SAEs) were collected through 6-months post-index procedure. Significant Adverse Events are defined as device or procedure-related adverse events (AE) 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 the event was an SAE. The SAE table combines both Significant Events and SAE events. Only AEs relevant to index-procedure, study device, access site or endoAVF were collected and are included in the Other AE table.

Other adverse events

Other adverse events
Measure	endoAVF n=32 participants at risk everlinQ arteriovenous fistula (endoAVF) System
Vascular disorders Occlusion/Thrombosis	12.5% 4/32 • Number of events 4 • Serious Adverse Events (SAEs) were collected through 6-months post-index procedure. Significant Adverse Events are defined as device or procedure-related adverse events (AE) 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 the event was an SAE. The SAE table combines both Significant Events and SAE events. Only AEs relevant to index-procedure, study device, access site or endoAVF were collected and are included in the Other AE table.
Vascular disorders Occlusion/Stenosis	3.1% 1/32 • Number of events 1 • Serious Adverse Events (SAEs) were collected through 6-months post-index procedure. Significant Adverse Events are defined as device or procedure-related adverse events (AE) 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 the event was an SAE. The SAE table combines both Significant Events and SAE events. Only AEs relevant to index-procedure, study device, access site or endoAVF were collected and are included in the Other AE table.
Blood and lymphatic system disorders Bleeding/Hematoma	6.2% 2/32 • Number of events 2 • Serious Adverse Events (SAEs) were collected through 6-months post-index procedure. Significant Adverse Events are defined as device or procedure-related adverse events (AE) 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 the event was an SAE. The SAE table combines both Significant Events and SAE events. Only AEs relevant to index-procedure, study device, access site or endoAVF were collected and are included in the Other AE table.

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