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

Primary Purpose

Vascular Access, End Stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
VasQ
Sponsored by
Laminate Medical Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vascular Access

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sheba Medical Center
  • Southmead Hospital
  • Guy's Hospital
  • St George's Healthcare

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

AV fistula with VasQ

AV fistula

Arm Description

Implant VasQ over AV fistula

AV fistula without any adjunct device

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Secondary efficacy endpoint: Percentage of AVF physiologically matured
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
Secondary efficacy endpoint: Primary patency of the study AVF, defined as percentage of patent AVF free from surgical or endovascular interventions
Secondary efficacy endpoint: Cephalic vein outflow as assess with Doppler ultrasound
Secondary efficacy endpoint: Secondary patency of the study AVF, defined as percentage of patent AVF following surgical or endovascular interventions

Full Information

First Posted
April 10, 2014
Last Updated
June 4, 2019
Sponsor
Laminate Medical Technologies
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1. Study Identification

Unique Protocol Identification Number
NCT02112669
Brief Title
A Multi Center, Study to Evaluate the Safety and Efficacy of the VasQ External Support Device for Arteriovenous Fistulas
Official Title
A Prospective, Multi Center, Study to Evaluate the Safety and Efficacy of the VasQ External Support Device for Brachiocephalic Arteriovenous Fistula
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laminate Medical Technologies

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Access, End Stage Renal Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AV fistula with VasQ
Arm Type
Experimental
Arm Description
Implant VasQ over AV fistula
Arm Title
AV fistula
Arm Type
No Intervention
Arm Description
AV fistula without any adjunct device
Intervention Type
Device
Intervention Name(s)
VasQ
Primary Outcome Measure Information:
Title
Primary safety endpoint: Freedom from severe (i.e. performance of daily activities is compromised) or unanticipated device related adverse events
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Secondary efficacy endpoint: Percentage of AVF physiologically matured
Description
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
Time Frame
3 months
Title
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
Title
Secondary efficacy endpoint: Cephalic vein outflow as assess with Doppler ultrasound
Time Frame
1, 3, and 6 months
Title
Secondary efficacy endpoint: Secondary patency of the study AVF, defined as percentage of patent AVF following surgical or endovascular interventions
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Southmead Hospital
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
Guy's Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
St George's Healthcare
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
31447072
Citation
Karydis N, Bevis P, Beckitt T, Silverberg D, Halak M, Calder F. An Implanted Blood Vessel Support Device for Arteriovenous Fistulas: A Randomized Controlled Trial. Am J Kidney Dis. 2020 Jan;75(1):45-53. doi: 10.1053/j.ajkd.2019.05.023. Epub 2019 Aug 22.
Results Reference
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A Multi Center, Study to Evaluate the Safety and Efficacy of the VasQ External Support Device for Arteriovenous Fistulas

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