Clinical trial NCT02112669: 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
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Access
End Stage Renal Disease
Lead sponsor: Laminate Medical Technologies
Sponsor class: INDUSTRY
First posted: 2014-04-14
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Primary safety endpoint: Freedom from severe (i.e. performance of daily activities is compromised) or unanticipated device related adverse events
timeFrame: 6 months
Secondary outcomes:
measure: Secondary efficacy endpoint: Percentage of AVF physiologically matured
timeFrame: 3 months
measure: Secondary efficacy endpoint: Primary patency of the study AVF, defined as percentage of patent AVF free from surgical or endovascular interventions
timeFrame: 6 months
measure: Secondary efficacy endpoint: Cephalic vein outflow as assess with Doppler ultrasound
timeFrame: 1, 3, and 6 months
measure: Secondary efficacy endpoint: Secondary patency of the study AVF, defined as percentage of patent AVF following surgical or endovascular interventions
timeFrame: 6 months
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: London
country: United Kingdom
facility: Guy's Hospital
city: London
country: United Kingdom
facility: St George's Healthcare
Study officials:
References:
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.