Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula

NCT06516653 | Recruiting FDA Device

• 1 other identifier: CD0261
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 7

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

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Other Outcomes (1)

• Safety - vascular access related complications

  1 year

Study Arms (2)

End to side fistula supported with VasQ

EXPERIMENTAL

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

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

Procedure: Arteriovenous fistula creation for dialysis vascular access

Interventions

VasQ DEVICE

External support implant for the arteriovenous fistula

End to side fistula supported with VasQ

Arteriovenous fistula creation for dialysis vascular access PROCEDURE

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

End to side fistula supported with VasQ; Standard of care end to side fistula

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Laminate Medical Technologies: lead

Study Sites (7)

Fresenius Vascular Care Long Beach

Long Beach, California, 90706, United States

RECRUITING

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Greenwood Leflore Hospital

Greenwood, Mississippi, 38930, United States

RECRUITING

Azura Surgery Center Las Vegas

Las Vegas, Nevada, 99128, United States

RECRUITING

Fresenius Vascular Care Columbia

Columbia, South Carolina, 29203, United States

RECRUITING

Fairlawn Surgery Center

Roanoke, Virginia, 24014, United States

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John F Lucas III, MD, FACS, FSVS

  Greenwood Leflore Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Galit Itzhaki

CONTACT

+972-3-6344246; galit@laminatemedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 24, 2024
• Study Start: January 13, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)