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VasQ External Support for Arteriovenous Fistula

Primary Purpose

Arterio-Venous Fistula, ESRD, Steal Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VasQ
Sponsored by
Laminate Medical Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arterio-Venous Fistula

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Main study cohort: Patients referred for creation of a new brachiocephalic fistula who consent to take part in the study and which are not indicated for a more distal fistula per treatment guidelines.

    Supplementary study cohort: Patients referred for creation of a new forearm fistula who consent to take part in the study.

  2. Male and female participants.
  3. Age 18-80 years.
  4. Patients willing and able to attend follow up visits over a period of 24 months.

Exclusion Criteria:

  1. Patients with the planned index procedure being a revision surgery of an existing fistula.

  2. Main study cohort: Target artery smaller than 2.5 mm or larger than 6 mm in inner diameter by preoperative ultrasound.

    Supplementary study cohort: Target artery smaller than 2 mm or larger than 4.1 mm in inner diameter by preoperative ultrasound.

  3. Main study cohort: Target vein smaller than 2.5 mm in inner diameter by preoperative ultrasound.

    Supplementary study cohort: Target vein smaller than 2 mm in inner diameter by preoperative ultrasound.

  4. Significantly stenotic target vein on the side of surgery (≥50%) as diagnosed on preoperative 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 ultrasound or intraoperatively) and which preclude adequate fit of the VasQ.
  6. Patients with 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.
  11. Known allergy to nitinol.
  12. Life expectancy less than 30 months.
  13. Patients expecting to undergo kidney transplant within 6 months of enrollment.
  14. Women of child bearing age without documented current negative pregnancy test.
  15. Inability to give consent and/or comply with the study follow up schedule.

Sites / Locations

  • Grandview Medical Center
  • Arizona Kidney Disease & Hypertension Center
  • Saint Francis Medical Center
  • Lutheran Medical Group/Indiana Ohio Heart
  • Brigham and Women's Hospital
  • Boston Medical Center
  • University of Michigan
  • Albany Medical College
  • Montefiore Medical Center
  • Charlotte PA
  • Duke University Medical Center
  • Ohio State University Wexner Meidcal Center
  • Greenville Health System
  • Cardiothoracic and Vascular Surgeons, P.A.
  • Methodist DeBakey Heart and Vascular Center,The Methodist Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VasQ device implantation

Arm Description

Main study cohort: Prospective, multi-center, single-arm, open label, enrolling patients referred to surgical creation of new brachiocephalic fistula (BCF). The VasQ will be applied to the AV fistula in all patients. The primary effectiveness endpoint for this trial will be measured at 6 months and compared to a performance goal (PG). Safety will compare descriptively between AE rates for Steal, Infection, Aneurysm and Seroma. Patients will be followed up for an additional 18 months for a total of 2 years. Additionally, this trial has several secondary endpoints. Supplementary study cohort: 15 patients will be prospectively enrolled which are referred to surgical creation of a new forearm arteriovenous fistula. VasQ will be applied to the AV fistula in all patients. Patients will be followed in the same manner as in the Main study cohort, however, the data will be reported separately and not be part of the analysis sets for the study primary and secondary endpoints.

Outcomes

Primary Outcome Measures

Primary Patency of AVF
Proportion of patients with freedom from intervention since device placement
Occurrence of safety events
The occurrence per patient access related safety events

Secondary Outcome Measures

Full Information

First Posted
August 3, 2017
Last Updated
October 5, 2023
Sponsor
Laminate Medical Technologies
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1. Study Identification

Unique Protocol Identification Number
NCT03242343
Brief Title
VasQ External Support for Arteriovenous Fistula
Official Title
A Multi-center Prospective Study to Evaluate the Safety and Effectiveness of the VasQ External Support for Arteriovenous Fistula
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 29, 2017 (Actual)
Primary Completion Date
October 8, 2020 (Actual)
Study Completion Date
April 3, 2022 (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
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a prospective clinical study of the VasQ external support for arteriovenous fistulas. The device is designed to improve fistula outcomes by optimizing the geometrical configuration of the fistula, influencing hemodynamics, minimizing turbulence and promote laminar flow. All patients will be implanted with the VasQ device and will be followed up for a duration of 24 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterio-Venous Fistula, ESRD, Steal Syndrome, Aneurysm, Renal Failure, Renal Disease, Diabetes Mellitus, Kidney Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VasQ device implantation
Arm Type
Experimental
Arm Description
Main study cohort: Prospective, multi-center, single-arm, open label, enrolling patients referred to surgical creation of new brachiocephalic fistula (BCF). The VasQ will be applied to the AV fistula in all patients. The primary effectiveness endpoint for this trial will be measured at 6 months and compared to a performance goal (PG). Safety will compare descriptively between AE rates for Steal, Infection, Aneurysm and Seroma. Patients will be followed up for an additional 18 months for a total of 2 years. Additionally, this trial has several secondary endpoints. Supplementary study cohort: 15 patients will be prospectively enrolled which are referred to surgical creation of a new forearm arteriovenous fistula. VasQ will be applied to the AV fistula in all patients. Patients will be followed in the same manner as in the Main study cohort, however, the data will be reported separately and not be part of the analysis sets for the study primary and secondary endpoints.
Intervention Type
Device
Intervention Name(s)
VasQ
Intervention Description
An external support device for AV fistula
Primary Outcome Measure Information:
Title
Primary Patency of AVF
Description
Proportion of patients with freedom from intervention since device placement
Time Frame
6 months post AVF creation
Title
Occurrence of safety events
Description
The occurrence per patient access related safety events
Time Frame
Device implantation to 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: Main study cohort: Patients referred for creation of a new brachiocephalic fistula who consent to take part in the study and which are not indicated for a more distal fistula per treatment guidelines. Supplementary study cohort: Patients referred for creation of a new forearm fistula who consent to take part in the study. Male and female participants. Age 18-80 years. Patients willing and able to attend follow up visits over a period of 24 months. Exclusion Criteria: Patients with the planned index procedure being a revision surgery of an existing fistula. Main study cohort: Target artery smaller than 2.5 mm or larger than 6 mm in inner diameter by preoperative ultrasound. Supplementary study cohort: Target artery smaller than 2 mm or larger than 4.1 mm in inner diameter by preoperative ultrasound. Main study cohort: Target vein smaller than 2.5 mm in inner diameter by preoperative ultrasound. Supplementary study cohort: Target vein smaller than 2 mm in inner diameter by preoperative ultrasound. Significantly stenotic target vein on the side of surgery (≥50%) as diagnosed on preoperative ultrasound. (Scan should include the area between the planned anastomosis site and the Axillary vein.) Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the VasQ. Patients with 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. Known allergy to nitinol. Life expectancy less than 30 months. Patients expecting to undergo kidney transplant within 6 months of enrollment. Women of child bearing age 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
Grandview Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Facility Name
Arizona Kidney Disease & Hypertension Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Lutheran Medical Group/Indiana Ohio Heart
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Montefiore Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Charlotte PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Ohio State University Wexner Meidcal Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Greenville Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Cardiothoracic and Vascular Surgeons, P.A.
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Methodist DeBakey Heart and Vascular Center,The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

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

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VasQ External Support for Arteriovenous Fistula

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