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

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02112669
• Other study ID #: Laminate CD0006
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: September 2017

Study information

• Verified date: June 2019
• Source: Laminate Medical Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Fistula
• End Stage Renal Disease
• Fistula
• Kidney Failure, Chronic
• Vascular Access

Intervention

Device:
• VasQ

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan
United Kingdom	Southmead Hospital	Bristol
United Kingdom	Guy's Hospital	London
United Kingdom	St George's Healthcare	London

Sponsors (1)

Lead Sponsor	Collaborator
Laminate Medical Technologies

Countries where clinical trial is conducted

Israel,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary safety endpoint: Freedom from severe (i.e. performance of daily activities is compromised) or unanticipated device related adverse events		6 months
Secondary	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	Secondary efficacy endpoint: Primary patency of the study AVF, defined as percentage of patent AVF free from surgical or endovascular interventions		6 months
Secondary	Secondary efficacy endpoint: Cephalic vein outflow as assess with Doppler ultrasound		1, 3, and 6 months
Secondary	Secondary efficacy endpoint: Secondary patency of the study AVF, defined as percentage of patent AVF following surgical or endovascular interventions		6 months