everlinQ Endovascular Access Systems Enhancements (EASE-2) Study

NCT ID: NCT03708562

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-16
• Study Completion Date: 2018-12-12

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.

Detailed Description

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.

Conditions

Chronic Kidney Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

endoAVF

Group Type: OTHER

everlinQ endoAVF System

Intervention Type: 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.

Interventions

everlinQ endoAVF System

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.

Intervention Type: DEVICE

Eligibility Criteria

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) at fistula site ≥ 2.0 mm.

5. Target artery diameter at fistula site ≥ 2.0 mm.

6. Procedural access site artery and vein diameter ≥ 2.0 mm.

7. At least one superficial outflow vein diameter ≥ 2.5 mm and in communication with the perforating vein.

8. Estimated life expectancy > 1 year.

9. Patient is free of clinically significant conditions or illness within 30 days prior to the AV fistula that may compromise the procedure.

10. Presence of an antecubital perforating vein diameter ≥ 2.0 mm.

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 the 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.

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. 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.

17. Evidence of calcification in vessels at the fistula site.

18. Evidence of active infections on the day of the index procedure.

19. Written informed consent not obtained.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adrian Ebner

Role: PRINCIPAL_INVESTIGATOR

Sanatorio Italiano, Paraguay

Locations

Sanatorio Italiano

Asunción, , Paraguay

Countries

Paraguay

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CD-0038

Identifier Type: -

Identifier Source: org_study_id