VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ

This is a prospective single arm study enrolling patients who are scheduled for creation of a new Brachiocephalic or Radiocephalic AV fistula. Up to 80 patients will be enrolled, 50 with upper arm AV fistula and 30 with forearm AV fistula. All patients will be implanted with the VasQ device, a subcutaneous arteriovenous conduit support for vascular access. The follow up period in this study will be for a duration of 12 months, with follow up visits scheduled at 1, 3, 6, 9, and 12 months.

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Key information

Conditions

Arterio-venous Fistula Arteriovenous Fistula Arteriovenous Fistula Thrombosis Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Chronic Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes ESRD Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fistula Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Failure Chronic Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases Vascular Fistula Vascular Malformations

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Mutualiste Montsouris, Paris, France

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 or radiocephalic fistula who consent to take part in the study.
Age 18-80 years
Male and female participants
Patients willing and able to attend follow up visits over a period of 12 months

Exclusion criteria

Patients with the planned index procedure being a revision surgery of an existing fistula.
Target Brachial artery smaller than 2.5 mm or larger than 6 mm or Radial artery smaller than 2.5 mm or larger than 4 mm in outer diameter by preoperative ultrasound
Target vein outer diameter smaller than 2.5 mm by preoperative ultrasound
Significantly stenotic target vein on the side of surgery (≥50%) as diagnosed on pre-op ultrasound (scan should include the area between the planned anastomosis site and the Axillary vein)
Unusual anatomy or vessel dimensions (observed on pre-operative US or intraoperatively) and which preclude adequate fit of the VasQ.
Patients with prior central venous stenosis or obstruction on the side of surgery
Depth of vein greater than 8 mm (on ultrasound) on side of surgery
Known coagulation disorder
Congestive heart failure NYHA class ≥ 3
Prior steal on the side of surgery as evident from the patient's medical history
Known allergy to nitinol
Life expectancy less than 18 months
Patients expected to undergo kidney transplant within 6 months of enrollment
Women of child bearing potential without documented current negative pregnancy test
Inability to give consent and/or comply with the study follow up schedule

Treatment and study plan

VasQ

Device

VasQ device implantation in patients with a new brachiocephalic or radiocephalic fistula creation.

Primary outcomes

Primary patency of AV fistula

Time frame: 6 months post AVF creation

Freedom from any intervention designed to maintain or reestablish patency since device placement and demonstrate flow on Doppler US.

1 = Success = Intervention free access patency determined by Doppler ultrasound.

0 = Failure = Access occluded determined by Doppler ultrasound and/or underwent intervention

Sponsors and collaborators

Lead sponsor

Laminate Medical Technologies

Industry

Registry information

Official study title

A Post Market Surveillance Multi-center Prospective Study to Evaluate the Safety and Efficacy of the VasQ External Support for Arteriovenous Fistula

Acronym: VALUE

Important dates

Study start: 2017
Primary completion: 2021
Study completion: 2021
First posted: Aug 11, 2017
Registry last updated: Jan 31, 2024

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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