everlinQ Endovascular Access Systems Enhancements (EASE-2) Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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everlinQ Endovascular Access Systems Enhancements (EASE-2) Study

Conditions
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Chronic Kidney Diseases

Intervention / Treatment
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* Device: everlinQ endoAVF System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible for a native arteriovenous fistula. Adult (age >18 years old). Established, non-reversible kidney failure requiring hemodialysis (including pre-dialysis patients). Target vein diameter(s) at fistula site ≥ 2.0 mm. Target artery diameter at fistula site ≥ 2.0 mm. Procedural access site artery and vein diameter ≥ 2.0 mm. At least one superficial outflow vein diameter ≥ 2.5 mm and in communication with the perforating vein. Estimated life expectancy > 1 year. Patient is free of clinically significant conditions or illness within 30 days prior to the AV fistula that may compromise the procedure. Presence of an antecubital perforating vein diameter ≥ 2.0 mm. Exclusion Criteria: Known central venous stenosis or central vein narrowing > 50% based on imaging on the same side as the planned AVF creation. 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. Prior surgically created access in the planned treatment location. Functioning surgical access in the planned treatment arm. Pregnant women. New York Heart Association (NYHA) class III or IV heart failure. Hypercoagulable state. Known bleeding diathesis. Immunosuppression, defined as use of immunosuppressive medications used to treat an active condition. Documented history of drug abuse including intravenous drugs within six months of AVF creation. Planned concomitant major surgical procedure within 6 months of enrollment or previous major surgery within 30 days of enrollment. Currently being treated with another investigational device or drug. Known allergy to contrast dye which cannot be adequately pre-medicated. Known adverse effects to sedation and/or anesthesia which cannot be adequately pre- medicated. Patients who do not have an ulnar or radial artery. 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. Evidence of calcification in vessels at the fistula site. Evidence of active infections on the day of the index procedure. Written informed consent not obtained.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: endoAVF<br> | Device: everlinQ endoAVF System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 3 months following endoAVF creation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 6 months post index procedure |