everlinQ Endovascular Access System Enhancements (EASE) Study

C. R. Bard32 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Kidney Diseases

Interventions

everlinQ endoAVF SystemDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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) ≥ 2.0 mm or large enough to accommodate device diameter. 5. Target artery diameter ≥ 2.0 mm or large enough to accommodate device diameter. 6. Estimated life expectancy \> 1 year. 7. Patient is free of clinically significant conditions or illness within 30 days prior to the AV fistula that may compromise the procedure 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 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. CD-0015 Rev 02 - EASE Study Clinical Protocol CONFIDENTIAL Page 8 of 16 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. At the time of procedure distance between target artery and vein will not allow magnets to align vessels sufficiently to create the fistula. 17. Evidence of active infections on the day of the index procedure. 18. Written informed consent not obtained.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 3 months following AVF creation

Secondary Outcomes

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).

Time frame: 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.

Time frame: 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.

Time frame: 6 months post-index procedure

Number of Participants Per Catheter Exposure Type

Data from ClinicalTrials.gov

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