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

Not Applicable

Recruiting

• Conditions: End Stage Renal Disease
• Interventions: Device: VasQ; Procedure: Arteriovenous fistula creation for dialysis vascular access

• Registration Number: NCT06516653
• Lead Sponsor: Laminate Medical Technologies

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

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 Timeline

• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-07-21
• Study First Posted: 2024-07-24
• Study Start: 2025-01-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-27
• Primary Completion: 2027-08
• Study Completion: 2028-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
End to side fistula supported with VasQ	VasQ	Patients receiving an end to side arteriovenous fistula, supported by VasQ, for fistula access
End to side fistula supported with VasQ	Arteriovenous fistula creation for dialysis vascular access	Patients receiving an end to side arteriovenous fistula, supported by VasQ, for fistula access
Standard of care end to side fistula	Arteriovenous fistula creation for dialysis vascular access	Patients receiving an end to side arteriovenous fistula, for fistula access

Primary Outcome Measures

Name	Time	Method
Fistula functional success	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

Trial Locations

Locations (3)

Sarasota Memorial Hospital; 🇺🇸 Sarasota, Florida, United States

Fairlawn Surgery Center; 🇺🇸 Roanoke, Virginia, United States

Greenwood Leflore Hospital; 🇺🇸 Greenwood, Mississippi, United States