NCT03708562

everlinQ Endovascular Access Systems Enhancements (EASE-2) Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2017-10-16
• Primary completion: 2018-12-12
• Completion: 2018-12-12
• First posted: 2018-10-17
• Last updated: 2025-12-11
• Results posted: 2020-01-02

Locations

1 site across 1 country: Paraguay