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

Recruiting now · Not applicable

Conditions studied: End Stage Renal Disease

In brief

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

Key facts

Study ID

NCT06516653

Run by

Laminate Medical Technologies

People needed

300

Starts

2025-01-13

Expected to finish

2028-05-01

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Fairlawn Surgery Center — Roanoke, Virginia, United States (enrolling)
• Sarasota Memorial Hospital — Sarasota, Florida, United States (enrolling)
• Grady Memorial Hospital — Atlanta, Georgia, United States (enrolling)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
• Greenwood Leflore Hospital — Greenwood, Mississippi, United States (enrolling)
• Fresenius Vascular Care Long Beach — Long Beach, California, United States (enrolling)
• Fresenius Vascular Care Columbia — Columbia, South Carolina, United States (enrolling)
• Houston Methodist Hospital — Houston, Texas, United States (enrolling)
• Azura Surgery Center Las Vegas — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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