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New device aims to keep dialysis fistulas working longer

NCT ID NCT03242343

Disease control Sponsor: Laminate Medical Technologies Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a device called VasQ that wraps around a surgically created blood vessel connection (fistula) used for dialysis in people with kidney failure. The device is designed to improve blood flow and reduce complications. 144 patients received the device and were followed for 24 months to see how well the fistula stayed open and how safe the device was.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VasQ external support device
What this could lead to
If successful, this device could help people with kidney failure have fewer fistula problems and need fewer interventions, making dialysis easier.
What could go wrong
This is a single-arm study with no comparison group, so benefits may not be confirmed. The device may not work for everyone and could still have risks like infection or steal syndrome.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

144 people

The number who actually took part.

Started

Nov 2017

Finished

Apr 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Aneurysm chronic kidney disease congenital arteriovenous fistula diabetes mellitus end stage renal failure kidney disorder kidney failure subclavian steal syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aneurysm Arterio-venous fistula Diabetes mellitus ESRD Kidney failure Renal disease Renal failure Steal syndrome

Contacts and locations

Locations

  • Albany Medical College

    Albany, New York, 12208, United States

  • Arizona Kidney Disease & Hypertension Center

    Phoenix, Arizona, 85012, United States

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Cardiothoracic and Vascular Surgeons, P.A.

    Austin, Texas, 78756, United States

  • Charlotte PA

    Charlotte, North Carolina, 28207, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Grandview Medical Center

    Birmingham, Alabama, 35243, United States

  • Greenville Health System

    Greenville, South Carolina, 29615, United States

  • Lutheran Medical Group/Indiana Ohio Heart

    Fort Wayne, Indiana, 46804, United States

  • Methodist DeBakey Heart and Vascular Center,The Methodist Hospital

    Houston, Texas, 77030, United States

  • Montefiore Medical Center

    New York, New York, 10467, United States

  • Ohio State University Wexner Meidcal Center

    Columbus, Ohio, 43210, United States

  • Saint Francis Medical Center

    Peoria, Illinois, 61637, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

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