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OpenTrials
Active, not recruiting

NCT Number: NCT07786025

DisTal Arterio-Venous Fistula Feasibility

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

End-Stage Renal Disease Requiring Haemodialysis Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Canela

La Romana, Dominican Republic

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Percutaneous DisTal AVF vein enlargement success rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Distal Inc.

Industry

Registry information

Official study title

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

Acronym: DisTal

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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