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

January 30, 2024 updated by: Laminate Medical Technologies

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Institut Mutualiste Montsouris
  • Germany
      • Augsburg, Germany, 86156
        • Universitätsklinikum Augsburg
      • Berlin, Germany, 13353
        • Charité - Universitätsmedizin Berlin
      • Berlin, Germany
        • Königin Elisabeth Krankenhaus Herzberge
      • Chemnitz, Germany, 09113
        • Klinikum Chemnitz gGmbH
      • Cologne, Germany, 50937
        • University Hospital Cologne
      • Jena, Germany
        • Universitaetsklinikum Jena
      • Potsdam, Germany, 14467
        • Klinikum Ernst von Bergmann gemeinnützige GmbH
      • Wernigerode, Germany
        • Harzklinikum Dorothea Christiane Erxleben
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic of Barcelona
  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Guy's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients referred for creation of a new brachiocephalic or radiocephalic fistula who consent to take part in the study.
  2. Age 18-80 years
  3. Male and female participants
  4. Patients willing and able to attend follow up visits over a period of 12 months

Exclusion Criteria:

  1. Patients with the planned index procedure being a revision surgery of an existing fistula.
  2. 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
  3. Target vein outer diameter smaller than 2.5 mm by preoperative ultrasound
  4. 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)
  5. Unusual anatomy or vessel dimensions (observed on pre-operative US or intraoperatively) and which preclude adequate fit of the VasQ.
  6. Patients with prior central venous stenosis or obstruction on the side of surgery
  7. Depth of vein greater than 8 mm (on ultrasound) on side of surgery
  8. Known coagulation disorder
  9. Congestive heart failure NYHA class ≥ 3
  10. Prior steal on the side of surgery as evident from the patient's medical history
  11. Known allergy to nitinol
  12. Life expectancy less than 18 months
  13. Patients expected to undergo kidney transplant within 6 months of enrollment
  14. Women of child bearing potential without documented current negative pregnancy test
  15. Inability to give consent and/or comply with the study follow up schedule

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VasQ device implantation
Device: VasQ
VasQ device implantation in patients with a new brachiocephalic or radiocephalic fistula creation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months post AVF creation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laminate Medical Technologies

Investigators

  • Study Director: Noam Zilberman, Laminate Medical Technologies Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2017

Primary Completion (Actual)

January 11, 2021

Study Completion (Actual)

January 11, 2021

Study Registration Dates

First Submitted

August 3, 2017

First Submitted That Met QC Criteria

August 10, 2017

First Posted (Actual)

August 11, 2017

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD0097

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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