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

Study Overview
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Brief Summary
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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.

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

Conditions
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Vascular Access, End Stage Renal Disease

Intervention / Treatment
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* Device: VasQ


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 |