everlinQ Endovascular Access System Enhancements (EASE) Study

Study Overview
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Brief Summary
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Prospective, single-center study to evaluate the everlinQ System when used to create an endoAVF in hemodialysis patients.

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 will be followed for up to 12 months post index procedure based on Investigator's discretion.

Official Title
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everlinQ Endovascular Access System Enhancements (EASE) 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) ≥ 2.0 mm or large enough to accommodate device diameter. Target artery diameter ≥ 2.0 mm or large enough to accommodate device diameter. 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 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 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. CD-0015 Rev 02 - EASE Study Clinical Protocol CONFIDENTIAL Page 8 of 16 Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated. Patients who do not have an ulnar or radial artery. At the time of procedure distance between target artery and vein will not allow magnets to align vessels sufficiently to create the fistula. 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
Maximum Age: 90 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> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Protocol-Defined endoAVF Maturation | 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. | Through 6 months post-index procedure | 
| Number of Participants With Device-Related SAEs | The safety Endpoint is protocol-defined as Device-Related SAE at 3 months. | 3 months following AVF creation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Days to Fistula Maturation | 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). | Days from Index Procedure | 
| Percentage of Participants With Secondary Patency at 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. | 6 months post-index procedure | 
| Primary Patency at 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. | 6 months post-index procedure | 
| Number of Participants Per Catheter Exposure Type | 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. | 1-7 days, 30 days, 3, and 6 months post-index procedure | 
| Number of Participants With Technical Success | 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. | 1-7 days following index-procedure | 
| Number of Endo-AVF-related Re-interventions | 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. | At 6 months follow-up |