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

Not Applicable

Completed

• Conditions: End Stage Renal Disease; Vascular Access
• Interventions: Device: VasQ

• Registration Number: NCT02112669
• Lead Sponsor: Laminate Medical Technologies

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-10
• Study First Submitted QC: 2014-04-10
• Study First Posted: 2014-04-14
• Study Start: 2014-06
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-04
• Last Update Posted: 2019-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AV fistula with VasQ	VasQ	Implant VasQ over AV fistula

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Secondary efficacy endpoint: Percentage of AVF physiologically matured	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
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

Trial Locations

Locations (4)

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel

Southmead Hospital; 🇬🇧 Bristol, United Kingdom

St George's Healthcare; 🇬🇧 London, United Kingdom

Guy's Hospital; 🇬🇧 London, United Kingdom