DisTal Arterio-Venous Fistula Feasibility

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07786025

Acronym

DisTal

Enrollment

100

Registered

2026-08-25

Start date

2024-12-02

Completion date

2027-03-01

Last updated

2026-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-Stage Renal Disease Requiring Haemodialysis

Keywords

DisTal, arteriovenous, fistula, radial, AVF

Brief summary

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.

Interventions

DEVICEDisTal

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Percutaneous DisTal AVF vein enlargement success rate	within 100 days of establishing DisTal AVF	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.

Countries

Dominican Republic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 26, 2026