everlinQ Endovascular Access System Enhancements (EASE) Study

NCT03708770 | Completed Results

• 1 other identifier: CD-0015
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Number of Days to Fistula Maturation

  Days from Index Procedure

• Percentage of Participants With Secondary Patency at 6 Months Post-Index Procedure

  6 months post-index procedure

• Primary Patency at 6 Months Post-index Procedure

  6 months post-index procedure

• Number of Participants Per Catheter Exposure Type

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

• Number of Participants With Technical Success

  1-7 days following index-procedure

Study Arms (1)

endoAVF

OTHER

Device: everlinQ endoAVF System

Interventions

everlinQ endoAVF System DEVICE

endoAVF

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• C. R. Bard: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Courtney Rothwell
• Organization: Becton Dickinson (BPV)

courtney.rothwell@bd.com

480.350.6037

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: October 17, 2018
• Study Start: July 27, 2015
• Primary Completion: June 19, 2017
• Study Completion: June 19, 2017
• Last Updated: December 11, 2025
• Results First Posted: June 14, 2019

Record last verified: 2025-11