Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula

October 29, 2025 updated by: Laminate Medical Technologies

Postmarket Surveillance, Prospective, Multicenter, Randomized, Controlled Study Evaluating the Performance of VasQ for Its Intended Use.

VasQ is an external support implant for arteriovenous fistulas created for dialysis access.

This is a postmarket surveillance, prospective, multi-center, randomized, controlled, open label trial enrolling 300 patients randomized into two study arms:

  • Treatment arm: End to side fistula supported with VasQ
  • Control: Standard of care end to side fistula

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Structure

This is a postmarket surveillance, prospective, multi-center, randomized, controlled, open label trial enrolling 300 patients randomized into two study arms:

  • Treatment arm: End to side fistula supported with VasQ
  • Control: Standard of care end to side fistula

Duration The primary endpoint is defined at 6 month post index procedure of fistula creation. Patients will be further followed up to 12 months post index procedure.

Main study question What is the magnitude of benefit of the VasQ device with regard to time to achieving a clinically functional AVF as compared to a comparable contemporary standard of care cohort?

Study Type

Interventional

Enrollment (Estimated)

300

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 Contact

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90706
        • Recruiting
        • Fresenius Vascular Care Long Beach
        • Contact:
        • Principal Investigator:
          • Anthony Becker, MD
    • Florida
      • Sarasota, Florida, United States, 34239
        • Recruiting
        • Sarasota Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Jason Wagner, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mohamad Hussain, MD
    • Mississippi
      • Greenwood, Mississippi, United States, 38930
        • Recruiting
        • Greenwood Leflore Hospital
        • Contact:
        • Principal Investigator:
          • John F Lucas, MD
    • Nevada
      • Las Vegas, Nevada, United States, 99128
    • South Carolina
      • Columbia, South Carolina, United States, 29203
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Fairlawn Surgery Center
        • Principal Investigator:
          • Ryan Evans, MD
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients who are candidates for the creation of a new radiocephalic or brachiocephalic end-to-side surgical AV fistula for dialysis access (per VasQ IFU and investigator clinical judgment) and consent to take part in the study.
  2. Male and non-pregnant female participants.
  3. Age 18-80 years
  4. Patients willing and able (physically and geographically) to attend follow up visits over a period of 12 months.

Exclusion Criteria:

  1. Index procedure being a revision surgery of an existing fistula.
  2. Significantly stenotic target vein on the side of surgery (≥50%) as diagnosed on preoperative ultrasound. (Scan should include the full length of the expected fistula outflow, starting at the planned anastomosis site)
  3. Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the VasQ.
  4. Known central venous stenosis or obstruction on the side of surgery.
  5. Pre-existing stents or stent grafts in the access circuit.
  6. Planned subsequent fistula superficialization procedure.
  7. Known coagulation disorder.
  8. Known allergy to nitinol.
  9. Expected kidney transplant within 12 months of enrollment.
  10. Inability to give consent and/or comply with the study follow up schedule.
  11. Insufficient or borderline life expectancy to allow for completion of study procedures and follow-up (12 Months).
  12. Participation in another interventional study that in the judgment of the investigator could confound study results.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: End to side fistula supported with VasQ
Patients receiving an end to side arteriovenous fistula, supported by VasQ, for fistula access
Device: VasQ
External support implant for the arteriovenous fistula
Procedure: Arteriovenous fistula creation for dialysis vascular access
End to side fistula creation in the arm for dialysis vascular access
Active Comparator: Standard of care end to side fistula
Patients receiving an end to side arteriovenous fistula, for fistula access
Procedure: Arteriovenous fistula creation for dialysis vascular access
End to side fistula creation in the arm for dialysis vascular access

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fistula functional success
Time Frame: 6 months
The time, in days, to the first day of a 28-day period in which the study fistula was able to be cannulated with two dialysis needles for at least 75% of dialysis sessions to achieve the prescribed dialysis
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety - vascular access related complications
Time Frame: 1 year
Comparable rate of access related complications (including major reintervention and cannulation related complications)
1 year

Collaborators and Investigators

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

Sponsor

Laminate Medical Technologies

Investigators

  • Principal Investigator: John F Lucas III, MD, FACS, FSVS, Greenwood Leflore Hospital

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)

January 13, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

July 16, 2024

First Submitted That Met QC Criteria

July 21, 2024

First Posted (Actual)

July 24, 2024

Study Record Updates

Last Update Posted (Estimated)

October 30, 2025

Last Update Submitted That Met QC Criteria

October 29, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD0261

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

product manufactured in and exported from the U.S.

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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