everlinQ Endovascular Access Systems Enhancements (EASE-2) Study

NCT03708562 | Completed Results

• 1 other identifier: CD-0038
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

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

  6 months post index procedure

• Number of Participants With EndoAVF Maturation at 1, 3, and 6 Months Post Index Procedure

  1, 3, and 6 months post index procedure

• Time to Cannulation (Months)

  Months from index procedure to cannulation

• Number of Participants With Cannulation Success at Defined Follow-up Intervals

  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

  6 months post index procedure

Study Arms (1)

endoAVF

OTHER

Device: everlinQ endoAVF System

Interventions

everlinQ endoAVF System DEVICE

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.

endoAVF

Eligibility Criteria

• Age: 18 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) 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.

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 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.

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (1)

Sanatorio Italiano

Asunción, Paraguay

Location

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

Study Officials

• Adrian Ebner

  Sanatorio Italiano, Paraguay

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

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: October 13, 2018
• First Posted: October 17, 2018
• Study Start: October 16, 2017
• Primary Completion: December 12, 2018
• Study Completion: December 12, 2018
• Last Updated: December 11, 2025
• Results First Posted: January 2, 2020

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)