NCT02112669

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

June 6, 2019

Status Verified

June 1, 2019

Enrollment Period

3.3 years

First QC Date

April 10, 2014

Last Update Submit

June 4, 2019

Conditions

Vascular AccessEnd Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (4)

  • Secondary efficacy endpoint: Percentage of AVF physiologically matured

    3 months

  • Secondary efficacy endpoint: Primary patency of the study AVF, defined as percentage of patent AVF free from surgical or endovascular interventions

    6 months

  • Secondary efficacy endpoint: Cephalic vein outflow as assess with Doppler ultrasound

    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

    6 months

Study Arms (2)

AV fistula with VasQ

EXPERIMENTAL

Implant VasQ over AV fistula

Device: VasQ

AV fistula

NO INTERVENTION

AV fistula without any adjunct device

Interventions

VasQDEVICE
AV fistula with VasQ

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Southmead Hospital

Bristol, BS10 5NB, United Kingdom

Location

Guy's Hospital

London, SE1 9RT, United Kingdom

Location

St George's Healthcare

London, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 31447072DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2014

First Posted

April 14, 2014

Study Start

June 1, 2014

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

June 6, 2019

Record last verified: 2019-06

Locations

IL(1)GB(3)