VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ (VALUE)
Primary Purpose
Arterio-Venous Fistula, Kidney Failure, Chronic, Kidney Diseases
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
VasQ
Sponsored by
About this trial
This is an interventional treatment trial for Arterio-Venous Fistula
Eligibility Criteria
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
Sites / Locations
- Institut Mutualiste Montsouris
- Universitätsklinikum Augsburg
- Charité - Universitätsmedizin Berlin
- Königin Elisabeth Krankenhaus Herzberge
- Klinikum Chemnitz gGmbH
- University Hospital Cologne
- Universitaetsklinikum Jena
- Klinikum Ernst von Bergmann gemeinnützige GmbH
- Harzklinikum Dorothea Christiane Erxleben
- Hospital Clinic of Barcelona
- Guy's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VasQ device implantation
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03246984
First Posted
August 3, 2017
Last Updated
April 11, 2021
Sponsor
Laminate Medical Technologies
1. Study Identification
Unique Protocol Identification Number
NCT03246984
Brief Title
VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ
Acronym
VALUE
Official Title
A Post Market Surveillance Multi-center Prospective Study to Evaluate the Safety and Efficacy of the VasQ External Support for Arteriovenous Fistula
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 7, 2017 (Actual)
Primary Completion Date
January 11, 2021 (Actual)
Study Completion Date
January 11, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laminate Medical Technologies
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterio-Venous Fistula, Kidney Failure, Chronic, Kidney Diseases, Renal Failure Chronic, ESRD, Arteriovenous Fistula Thrombosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VasQ device implantation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
VasQ
Intervention Description
VasQ device implantation in patients with a new brachiocephalic or radiocephalic fistula creation.
Primary Outcome Measure Information:
Title
Primary patency of AV fistula
Description
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
Time Frame
6 months post AVF creation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noam Zilberman
Organizational Affiliation
Laminate Medical Technologies Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Universitätsklinikum Augsburg
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Königin Elisabeth Krankenhaus Herzberge
City
Berlin
Country
Germany
Facility Name
Klinikum Chemnitz gGmbH
City
Chemnitz
ZIP/Postal Code
09113
Country
Germany
Facility Name
University Hospital Cologne
City
Cologne
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitaetsklinikum Jena
City
Jena
Country
Germany
Facility Name
Klinikum Ernst von Bergmann gemeinnützige GmbH
City
Potsdam
ZIP/Postal Code
14467
Country
Germany
Facility Name
Harzklinikum Dorothea Christiane Erxleben
City
Wernigerode
Country
Germany
Facility Name
Hospital Clinic of Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Guy's Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27079670
Citation
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.
Results Reference
background
Links:
URL
http://www.laminatemedical.com/
Description
Related Info
Learn more about this trial
VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ
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