Recruiting

VasQ

Sponsor:

Laminate Medical Technologies

Code:

NCT06516653

Conditions

End Stage Renal Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

VasQ

Arteriovenous fistula creation for dialysis vascular access

Study Details

Brief 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: Standard of care end to side fistula

Conditions

End Stage Renal Disease

Study ID

NCT06516653

Start date

Jan 13, 2025

Status verified date

Oct, 2025

Completion date

May, 2028

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: End to side fistula supported with VasQ

Patients receiving an end to side arteriovenous fistula, supported by VasQ, for fistula access

active comparator: Standard of care end to side fistula

Patients receiving an end to side arteriovenous fistula, for fistula access

Interventions

VasQ

External support implant for the arteriovenous fistula

Arteriovenous fistula creation for dialysis vascular access

End to side fistula creation in the arm for dialysis vascular access

Primary outcome measure

  • Fistula functional success [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Fresenius Vascular Care Long Beach

Recruiting

Long Beach, California, United States, 90706

Contacts

Principal Investigator:

Anthony Becker, MD

Sarasota Memorial Hospital

Recruiting

Sarasota, Florida, United States, 34239

Contacts

Principal Investigator:

Jason Wagner, MD

Grady Memorial Hospital

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Principal Investigator:

Christopher Ramos, MD

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Principal Investigator:

Mohamad Hussain, MD

Greenwood Leflore Hospital

Recruiting

Greenwood, Mississippi, United States, 38930

Contacts

Principal Investigator:

John F Lucas, MD

Fresenius Vascular Care Columbia

Recruiting

Columbia, South Carolina, United States, 29203

Contacts

Principal Investigator:

Dion Franga, MD

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Eric Peden, MD

Fairlawn Surgery Center

Recruiting

Roanoke, Virginia, United States, 24014

Contacts

Principal Investigator:

Ryan Evans, MD

More Information

Sponsor

Laminate Medical Technologies

Last update posted

Jul 14, 2026

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Laminate Medical Technologies on 2026-07-14.