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Completed

NCT Number: NCT02112669

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

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.

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Key information

Conditions

Vascular Access Chronic Disease Disease Attributes End Stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheba Medical Center, Ramat Gan, Israel

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VasQ

Device

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

  1. Secondary efficacy endpoint: Percentage of AVF physiologically matured

    Time frame: 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

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

    Time frame: 6 months

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

    Time frame: 1, 3, and 6 months

  4. Secondary efficacy endpoint: Secondary patency of the study AVF, defined as percentage of patent AVF following surgical or endovascular interventions

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Laminate Medical Technologies

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 14, 2014
Registry last updated
Jun 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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