DisTal Arterio-Venous Fistula Feasibility

Feasibility Study to Assess the Safety and Efficacy of the DisTal Arterio-Venous Fistula Procedure

The goal of this clinical trial is to evaluate, in a clinical setting, the feasibility of vein enlargement at the site of the arteriovenous fistula created percutaneously, using the DisTal device ("DisTal AVF"). The main question the study aims to answer is what is the rate of successful enlargement of the vein at the site of DisTal AVF within 100 days of the procedure, as confirmed by ultrasound.

Inclusion Criteria:

1. Age ≥ 18.
2. End Stage Renal Disease (ESRD) requiring hemodialysis.
3. Having a patent cephalic vein at the wrist /forearm.
4. Signed informed consent.

Exclusion Criteria:

1. Pregnancy or lactation.
2. Known central venous stenosis on the same side as the planned AVF creation.
3. Prior surgically created access in the planned treatment location.
4. Evidence of active infections at the time of study enrollment.
5. Known uncontrolled abnormal coagulation status and are at additional risk for clotting or excessive bleeding.
6. Prisoner.
7. Employee of the Sponsor.