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VasQ External Support for Arteriovenous Fistula | Clinical Trials | Clareo Health

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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

NCT03242343•Laminate Medical Technologies

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

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.
+7 more criteria

Locations (15)

Grandview Medical Center

Birmingham, Alabama, United States

Arizona Kidney Disease & Hypertension Center

Phoenix, Arizona, United States

Saint Francis Medical Center

Peoria, Illinois, United States

Lutheran Medical Group/Indiana Ohio Heart

Fort Wayne, Indiana, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Boston Medical Center

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Albany Medical College

Albany, New York, United States

Montefiore Medical Center

New York, New York, United States

Charlotte PA

Charlotte, North Carolina, United States

Key Dates

Start Date

November 29, 2017

Primary Completion Date

October 8, 2020

Completion Date

April 3, 2022

Last Updated

October 6, 2023

Enrollment

144

ACTUAL participants

Conditions

Arterio-Venous FistulaESRDSteal SyndromeAneurysmRenal FailureRenal DiseaseDiabetes MellitusKidney Failure

Interventions

VasQ

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 6, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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VasQ External Support for Arteriovenous Fistula

Inclusion Criteria

Exclusion Criteria

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