End Stage Renal DiseaseNCT06516653
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
A study testing VasQ and Arteriovenous fistula creation for dialysis vascular access in people with End Stage Renal Disease, run by Laminate Medical Technologies at 13 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- VasQ and Arteriovenous fistula creation for dialysis vascular access
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 13 sitesUnited States
- Study dates
- 13 Jan 2025to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
- Male and non-pregnant female participants.
- Age 18-80 years
- Patients willing and able (physically and geographically) to attend follow up visits over a period of 12 months.
Who cannot join
- Index procedure being a revision surgery of an existing fistula.
- 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)
- Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the VasQ.
- Known central venous stenosis or obstruction on the side of surgery.
- Pre-existing stents or stent grafts in the access circuit.
- Planned subsequent fistula superficialization procedure.
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- Known coagulation disorder.
- Known allergy to nitinol.
- Expected kidney transplant within 12 months of enrollment.
- Inability to give consent and/or comply with the study follow up schedule.
- Insufficient or borderline life expectancy to allow for completion of study procedures and follow-up (12 Months).
- Participation in another interventional study that in the judgment of the investigator could confound study results.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 12 recruiting
- Recruiting
Grady Memorial Hospital
Atlanta, Georgia, 30303
Ronnie Adams, 404-251-8984, rwadam2@emory.edu
Christopher Ramos, MD
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Danielle Montano, 617-525-8555, dmontano2@bwh.harvard.edu
Navya Kotturu, 617-525-8555, nkotturu@bwh.harvard.edu
- Recruiting
Fresenius Vascular Care Columbia
Columbia, South Carolina, 29203
Alicia Phillips-Pough, 803-252-3373, alicia.phillips-pough@azuracare.com
Tami Hardwick, 803-252-3373, tami.hardwick@azuracare.com
- Not yet recruiting
Atlanta VA Medical Center
Decatur, Georgia, 30033
Adriana Gutrierrez Yllu, 404-729-6350, Adriana.Gutierrezyllu@va.gov
Maddie Sancheti, 404-321-6111, madhur.sancheti@va.gov
- Recruiting
Greenwood Leflore Hospital
Greenwood, Mississippi, 38930
Kimberly McMillian, 662-453-4641, kmcmillian@glh.org
John F Lucas, MD
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Abhiraj Sinha, 404-251-8984, asinha@houstonmethodist.org
Eric Peden, MD
- Active, not recruiting
Azura Surgery Center Las Vegas
Las Vegas, Nevada, 99128
- Recruiting
Fresenius Vascular Care Long Beach
Long Beach, California, 90706
Deann Helton, 562-888-8961, Deann.Helton@azuracare.com
Anthony Becker, MD
- Not yet recruiting
James E. Gardner MD, P.C.
Memphis, Tennessee, 38115
Hannah Touliatos, 901-604-0345, hannahgardner3@gmail.com
James Gardner, MD
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Stephen R Gannon, 615-936-6809, stephen.r.gannon@vumc.org
Robert Shahverdyan, MD
- Recruiting
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Shannon Williams, 504-842-6487, slwilliams@ochsner.org
Waldemar Sternbergh, MD
- Recruiting
Fairlawn Surgery Center
Roanoke, Virginia, 24014
Aleisha Umber, RN, 540-904-6170, AUMBER@FSCMED.COM
Ryan Evans, MD
- Recruiting
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Kaitlyn Meek, RN, 941-917-7109, kaitlyn-meek@smh.com
Jason Wagner, MD
About this study
Official title: 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
Read the 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?
- Conditions
- End Stage Renal Disease
- Being tested
- VasQ, Arteriovenous fistula creation for dialysis vascular access
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VasQDevice
External support implant for the arteriovenous fistula
Arteriovenous fistula creation for dialysis vascular accessProcedure or surgery
End to side fistula creation in the arm for dialysis vascular access
| Study group | Role | What they receive |
|---|---|---|
| End to side fistula supported with VasQ | Experimental | Patients receiving an end to side arteriovenous fistula, supported by VasQ, for fistula access Receives: Device: VasQ; Procedure: Arteriovenous fistula creation for dialysis vascular access |
| Standard of care end to side fistula | Active comparator | Patients receiving an end to side arteriovenous fistula, for fistula access Receives: Procedure: Arteriovenous fistula creation for dialysis vascular access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fistula functional success
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start13 Jan 2025
- Primary completionAug 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laminate Medical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John F Lucas III, MD FACS FSVS, Principal investigator, Greenwood Leflore Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516653
- Sponsor's protocol ID
- CD0261
- Status last verified
- Oct 2025
- First submitted
- 16 Jul 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postmarket Surveillance, Prospective, Multicenter, Randomized, Controlled Study Evaluating the Performance of VasQ for Its Intended Use.
- ClinicalTrials.gov ID
- NCT06516653
- Acronym / sponsor ID
- CD0261
- Conditions
- End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Laminate Medical TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| End to side fistula supported with VasQ | Experimental | Device: VasQ, Procedure: Arteriovenous fistula creation for dialysis vascular accessPatients receiving an end to side arteriovenous fistula, supported by VasQ, for fistula access |
| Standard of care end to side fistula | Active comparator | Procedure: Arteriovenous fistula creation for dialysis vascular accessPatients receiving an end to side arteriovenous fistula, for fistula access |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- Male and non-pregnant female participants.
- Age 18-80 years
- Patients willing and able (physically and geographically) to attend follow up visits over a period of 12 months.
Key exclusion criteria (12 listed)
- Index procedure being a revision surgery of an existing fistula.
- 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)
- Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the VasQ.
- Known central venous stenosis or obstruction on the side of surgery.
- Pre-existing stents or stent grafts in the access circuit.
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 |
|---|---|---|
| VasQExternal support implant for the arteriovenous fistula | Device | End to side fistula supported with VasQ |
| Arteriovenous fistula creation for dialysis vascular accessEnd to side fistula creation in the arm for dialysis vascular access | Procedure or surgery | End to side fistula supported with VasQ, Standard of care end to side fistula |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- 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.
John F Lucas III, MD FACS FSVS principal investigator
Greenwood Leflore Hospital
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VasQ and Arteriovenous fistula creation for dialysis vascular access in people with End Stage Renal Disease, run by Laminate Medical Technologies at 13 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 4 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Galit Itzhaki (+972-3-6344246, galit@laminatemedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fistula functional success (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2026.