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

June 4, 2019 updated by: Laminate Medical Technologies

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat Gan, Israel, 52621
        • Sheba Medical Center
  • United Kingdom
      • Bristol, United Kingdom, BS10 5NB
        • Southmead Hospital
      • London, United Kingdom, SE1 9RT
        • Guy's Hospital
      • London, United Kingdom
        • St George's Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AV fistula with VasQ
Implant VasQ over AV fistula
Device: VasQ
No Intervention: AV fistula
AV fistula without any adjunct device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary safety endpoint: Freedom from severe (i.e. performance of daily activities is compromised) or unanticipated device related adverse events
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary efficacy endpoint: Percentage of AVF physiologically matured
Time Frame: 3 months
Successful physiological maturation was defined by a minimum of 5 mm cephalic vein diameter with volume outflow greater than 500 mL/min confirmed by color duplex spectral analysis
3 months
Secondary efficacy endpoint: Primary patency of the study AVF, defined as percentage of patent AVF free from surgical or endovascular interventions
Time Frame: 6 months
6 months
Secondary efficacy endpoint: Cephalic vein outflow as assess with Doppler ultrasound
Time Frame: 1, 3, and 6 months
1, 3, and 6 months
Secondary efficacy endpoint: Secondary patency of the study AVF, defined as percentage of patent AVF following surgical or endovascular interventions
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laminate Medical Technologies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

April 10, 2014

First Submitted That Met QC Criteria

April 10, 2014

First Posted (Estimate)

April 14, 2014

Study Record Updates

Last Update Posted (Actual)

June 6, 2019

Last Update Submitted That Met QC Criteria

June 4, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Laminate CD0006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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