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DisTal Arterio-Venous Fistula Feasibility
Sponsor: Distal Inc.
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.
Official title: Feasibility Study to Assess the Safety and Efficacy of the DisTal Arterio-Venous Fistula Procedure
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2024-12-02
Completion Date
2027-03-01
Last Updated
2026-08-25
Healthy Volunteers
No
Interventions
DisTal
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.
Locations (1)
Clinica Canela
La Romana, Dominican Republic