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

NCT03246984 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-01-31

No results posted yet for this study

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.

Conditions

  • Arterio-Venous Fistula
  • Kidney Failure, Chronic
  • Kidney Diseases
  • Renal Failure Chronic
  • ESRD
  • Arteriovenous Fistula Thrombosis

Interventions

DEVICE

VasQ

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

Sponsors & Collaborators

  • Laminate Medical Technologies

    lead INDUSTRY

Principal Investigators

  • Noam Zilberman · Laminate Medical Technologies Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-07
Primary Completion
2021-01-11
Completion
2021-01-11

Countries

  • France
  • Germany
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03246984 on ClinicalTrials.gov