VasQ External Support for Arteriovenous Fistula

A Multi-center Prospective Study to Evaluate the Safety and Effectiveness of the VasQ External Support for Arteriovenous Fistula

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Renal Failure; ESRD; Aneurysm; Kidney Failure; Renal Disease; Arterio-Venous Fistula; Steal Syndrome
• Intervention / Treatment: Device: VasQ

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Grandview Medical Center
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Arizona Kidney Disease & Hypertension Center
  • Illinois
    • Peoria, Illinois, United States, 61637
      • Saint Francis Medical Center
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Lutheran Medical Group/Indiana Ohio Heart
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College
    • New York, New York, United States, 10467
      • Montefiore Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Charlotte PA
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Wexner Meidcal Center
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Greenville Health System
  • Texas
    • Austin, Texas, United States, 78756
      • Cardiothoracic and Vascular Surgeons, P.A.
    • Houston, Texas, United States, 77030
      • Methodist DeBakey Heart and Vascular Center,The Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: VasQ device implantation; 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.

Device: VasQ; An external support device for AV fistula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Patency of AVF	Proportion of patients with freedom from intervention since device placement	6 months post AVF creation
Occurrence of safety events	The occurrence per patient access related safety events	Device implantation to 6 months post AVF creation

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2017
• Primary Completion (Actual): October 8, 2020
• Study Completion (Actual): April 3, 2022

Study Registration Dates

• First Submitted: August 3, 2017
• First Submitted That Met QC Criteria: August 3, 2017
• First Posted (Actual): August 8, 2017

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Fistula; Renal Insufficiency; Aneurysm; Arteriovenous Fistula
• Other Study ID Numbers: CD0121

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: Yes