VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ
VALUE
A Post Market Surveillance Multi-center Prospective Study to Evaluate the Safety and Efficacy of the VasQ External Support for Arteriovenous Fistula
1 other identifier
interventional
80
4 countries
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2017
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2017
CompletedFirst Posted
Study publicly available on registry
August 11, 2017
CompletedStudy Start
First participant enrolled
September 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 11, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 11, 2021
CompletedJanuary 31, 2024
January 1, 2024
3.3 years
August 3, 2017
January 30, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Primary patency of AV fistula
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
6 months post AVF creation
Study Arms (1)
VasQ device implantation
EXPERIMENTALInterventions
VasQ device implantation in patients with a new brachiocephalic or radiocephalic fistula creation.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Institut Mutualiste Montsouris
Paris, 75014, France
Universitätsklinikum Augsburg
Augsburg, 86156, Germany
Charité - Universitätsmedizin Berlin
Berlin, 13353, Germany
Königin Elisabeth Krankenhaus Herzberge
Berlin, Germany
Klinikum Chemnitz gGmbH
Chemnitz, 09113, Germany
University Hospital Cologne
Cologne, 50937, Germany
Universitaetsklinikum Jena
Jena, Germany
Klinikum Ernst von Bergmann gemeinnützige GmbH
Potsdam, 14467, Germany
Harzklinikum Dorothea Christiane Erxleben
Wernigerode, Germany
Hospital Clinic of Barcelona
Barcelona, 08036, Spain
Guy's Hospital
London, SE1 9RT, United Kingdom
Related Publications (1)
Chemla E, Velazquez CC, D'Abate F, Ramachandran V, Maytham G. Arteriovenous fistula construction with the VasQ external support device: a pilot study. J Vasc Access. 2016 May 7;17(3):243-8. doi: 10.5301/jva.5000527. Epub 2016 Apr 14.
PMID: 27079670BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Noam Zilberman
Laminate Medical Technologies Ltd.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2017
First Posted
August 11, 2017
Study Start
September 7, 2017
Primary Completion
January 11, 2021
Study Completion
January 11, 2021
Last Updated
January 31, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share