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NCT06516653NARecruiting

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

Laminate Medical Technologies

Start Date

1/13/2025

Completion Date

5/1/2028

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

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?

Eligibility Criteria

Age Range: 18 years to 80 years

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.

Interventions

DEVICE

VasQ

PROCEDURE

Arteriovenous fistula creation for dialysis vascular access

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Conditions

End Stage Renal Disease

Locations

Fresenius Vascular Care Long Beach

Long Beach, California 90706

United States

Sarasota Memorial Hospital

Sarasota, Florida 34239

United States

Grady Memorial Hospital

Atlanta, Georgia 30303

United States

Brigham and Women's Hospital

Boston, Massachusetts 02115

United States

Greenwood Leflore Hospital

Greenwood, Mississippi 38930

United States

Azura Surgery Center Las Vegas

Las Vegas, Nevada 99128

United States

Fresenius Vascular Care Columbia

Columbia, South Carolina 29203

United States

Houston Methodist Hospital

Houston, Texas 77030

United States

Fairlawn Surgery Center

Roanoke, Virginia 24014

United States