DisTal Arterio-Venous Fistula Feasibility

NCT07786025 | Active Not Recruiting

• 1 other identifier: CLD-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

End-Stage Renal Disease Requiring Haemodialysis

Keywords

DisTal; arteriovenous; fistula; radial; AVF

Outcome Measures

Primary Outcomes (1)

• 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.

  within 100 days of establishing DisTal AVF

Study Arms (1)

DisTal

EXPERIMENTAL

If the eligibility criteria are fulfilled, participants undergo procedure during which DisTal is used to establish a percutaneous arteriovenous fistula ("DisTal AVF").

Device: DisTal

Interventions

DisTal DEVICE

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.

DisTal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Distal Inc.: lead

Study Sites (1)

Clinica Canela

La Romana, Dominican Republic

Location

MeSH Terms

Conditions

Fistula

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 25, 2026
• Study Start: December 2, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

DO (1)