Arterio-Venous FistulaNCT03242343

VasQ External Support for Arteriovenous Fistula

A study testing VasQ in people with Arterio-Venous Fistula and ESRD, run by Laminate Medical Technologies at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Arterio-Venous Fistula, ESRD, Steal Syndrome
What is being tested?: VasQ
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 144 participants
Where: 15 sitesUnited States
Study dates: 29 Nov 2017to 3 Apr 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.)

Show all 17Show fewer

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.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

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

Other trials in United States

About this study

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

All patients will be implanted with the VasQ device and will be followed up for a duration of 24 months.

Conditions: Arterio-Venous Fistula, ESRD, Steal Syndrome, Aneurysm, Renal Failure, Renal Disease
Being tested: VasQ
Medical subject headings: Arteriovenous Fistula, Kidney Failure, Chronic, Aneurysm, Renal Insufficiency, Kidney Diseases, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VasQDevice
An external support device for AV fistula

Study groups in NCT03242343
Study group	Role	What they receive
VasQ device implantation	Experimental	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. Receives: Device: VasQ

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary Patency of AVF
Proportion of patients with freedom from intervention since device placement
Measured: 6 months post AVF creation
Number of Participants With Access Related Safety Events
Number of participants with access related steal syndrome, AVF infection, AVF aneurysm, or seroma
Measured: Device implantation to 6 months post AVF creation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Nov 20173 Apr 2022

First posted8 Aug 2017
Study start29 Nov 2017
Primary completion8 Oct 2020
Study completion3 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Arterio-Venous FistulaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 144 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03242343
Sponsor's protocol ID: CD0121
Status last verified: Apr 2026
First submitted: 3 Aug 2017
Last updated: 27 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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.
PubMed 27079670

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center Prospective Study to Evaluate the Safety and Effectiveness of the VasQ External Support for Arteriovenous Fistula
ClinicalTrials.gov ID: NCT03242343
Acronym / sponsor ID: CD0121
Conditions: Arterio-Venous Fistula, ESRD, Steal Syndrome, Aneurysm, Renal Failure, Renal Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 144 participants (actual)
Lead sponsor: Laminate Medical TechnologiesIndustry (pharma, biotech, devices)
Study start: 29 Nov 2017 (actual)
Primary completion: 8 Oct 2020 (actual)
Study completion: 3 Apr 2022 (actual)
First posted: 8 Aug 2017 (actual)
Results: Posted 27 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

All patients will be implanted with the VasQ device and will be followed up for a duration of 24 months.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
VasQ device implantation	Experimental	Device: VasQMain 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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (17 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VasQAn external support device for AV fistula	Device	VasQ device implantation

Primary outcome

Primary Patency of AVF
Time frame: 6 months post AVF creation
Proportion of patients with freedom from intervention since device placement
Number of Participants With Access Related Safety Events
Time frame: Device implantation to 6 months post AVF creation
Number of participants with access related steal syndrome, AVF infection, AVF aneurysm, or seroma

Results and safety

Results posted to the registry on 27 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VasQ Device Implantation	144	144

Primary outcome: Primary Patency of AVF

Time frame: 6 months post AVF creation. Count of participants. Unit: Participants

Measure	VasQ Device Implantation n = 134
Value	88

Primary outcome: Number of Participants With Access Related Safety Events

Time frame: Device implantation to 6 months post AVF creation. Count of participants. Unit: Participants

Measure	VasQ Device Implantation n = 144
Value	4

Adverse events

Time frame: 2 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VasQ Device Implantation	9 of 144 (6.3%)	0 of 144 (0%)	21 of 144

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27079670Chemla 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.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Noam Zilberman study director

Laminate Medical Technologies Ltd.

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing VasQ in people with Arterio-Venous Fistula and ESRD, run by Laminate Medical Technologies at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Patency of AVF (time frame: 6 months post AVF creation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03242343, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.