DisTal Arterio-Venous Fistula Feasibility

N/AActive Not RecruitingNCT07786025

Distal Inc.100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

End-Stage Renal Disease Requiring Haemodialysis

Interventions

DisTalDEVICE

To create a DisTal arteriovenous fistula, the radial vein and radial artery are accessed percutaneously. Venous and arterial guidewires are inserted-with the arterial wire navigating from the vein into the artery-and aligned in position. The DisTal device, featuring a circular blade on a torque shaft, is advanced over both wires. As it advances, DisTal pulls the vessels together while the blade cuts a 7-10 mm opening between the adjoining artery and vein, establishing a non-surgical, endovascular arteriovenous fistula that allows direct blood flow.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Clinica Canela

La Romana, Dominican Republic

Outcomes

Primary Outcomes

Percutaneous DisTal AVF vein enlargement success rate

Proportion of participants in whom the vein at the site of the DisTal AVF exhibits enlargement compared to the pre-procedural values, as confirmed by ultrasound.

Time frame: within 100 days of establishing DisTal AVF

Data from ClinicalTrials.gov

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