NCT03024372

Continuous Suturing Versus Interrupted Clips for Brachiocephalic AV Fistula Creation

A Prospective Randomized Single Blinded Study of Continuous Suturing Versus Interrupted Clips for Brachiocephalic AV Fistula Creation

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of South Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate a promising strategy to improve maturation and patency rates following creation of AV fistulas and assess whether an anastomosis performed with Anastoclips (interrupted, nonpenetrating) would produce better maturation and/or patency than one performed with conventional suturing techniques.

Detailed description

This will be a single blind (patient and dialysis center), prospective, randomized trial conducted at a single center. The study intervention will be randomization between conventional sutured anastomosis (Control group) and use of Anastoclips (Treatment group), which provide an interrupted closure without intimal penetration.

Conditions

• Arteriovenous Fistula

Interventions

Type	Name	Description
DEVICE	AV Fistula creation with sutures	End-to-side anastomosis (of AV fistula) is to be constructed using sutures. The incision is to be irrigated and closed using Vicryl, Biosyn and skin glue.
DEVICE	AV Fistula creation with clips	End-to-side anastomosis (of AV fistula) is to be constructed using clips. The incision is to be irrigated and closed using Vicryl, Biosyn and skin glue.

Timeline

• Start date: 2017-12-01
• Primary completion: 2024-02-01
• Completion: 2024-08-01
• First posted: 2017-01-18
• Last updated: 2018-07-06

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study