A Multi Center, Study to Evaluate the Safety and Efficacy of the VasQ External Support Device for Arteriovenous Fistulas

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-09-30

Brief Summary

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This study is a prospective, multi center, randomized, controlled study of the VasQ in arteriovenous fistulas. The VasQ constraints and directs the geometrical parameters of the fistula as well as the vascular diameter and gradient in the vicinity of the AV shunt. These geometrical constraints direct flow and influence hemodynamics, and hence minimize turbulence and promote laminar flow. The device is designed to improve short term maturation and long term patency of the fistula. The VasQ is a permanent implant intended for use as a subcutaneous arteriovenous conduit support for vascular access.

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Detailed Description

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Conditions

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Vascular Access End Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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AV fistula with VasQ

Implant VasQ over AV fistula

Group Type EXPERIMENTAL

VasQ

Intervention Type DEVICE

AV fistula

AV fistula without any adjunct device

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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VasQ

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients referred for creation of a new brachiocephalic fistula who consent to take part in the study.
* Aged \> 18
* Male and female participants
* Patients willing and able to attend follow up visits over a period of 6 months

Exclusion Criteria

* Patients who require revision surgery.
* Having had previous arteriovenous fistula surgery is not a contraindication to recruitment provided the new procedure is not revision surgery
* Target arteries smaller than 3 mm in diameter
* Target vein smaller than 3 mm in diameter
* Stenotic veins on the side of surgery as diagnosed on pre-op ultrasound
* Patients with prior central venous stenosis or obstruction on the side of surgery
* Depth of vein greater than 8 mm (on US) on side of surgery
* Known coagulation disorder
* Prior steal
* Known allergy to nitinol
* Life expectancy less than 6 months
* Inability to give consent and/or comply with the study follow up schedule
* Women of child bearing age

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No