External support implant for arteriovenous fistula in dialysis patients

Postmarket Surveillance, Prospective, Multicenter, Randomized, Controlled Study Evaluating the Performance of VasQ for Its Intended Use.

This study is testing if a new device called VasQ can help create better access points for dialysis in patients with kidney failure compared to standard methods.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Laminate Medical Technologies (Industry-sponsored)
• Locations: 7 sites (Long Beach, California and 6 other locations)
• Trial ID: NCT06516653 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the VasQ device, an external support implant designed to enhance the creation of arteriovenous fistulas (AVF) for dialysis access in patients with end-stage renal disease. It is a postmarket, multi-center, randomized, controlled trial involving 300 participants who will be divided into two groups: one receiving the VasQ-supported fistula and the other receiving standard care. The primary endpoint is to assess the time to achieving a clinically functional AVF at six months post-procedure, with follow-up extending to twelve months. The study aims to determine the effectiveness of the VasQ device compared to conventional methods.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 who require a new arteriovenous fistula for dialysis access and can commit to follow-up visits.

Not a fit: Patients with existing fistula revisions, significant vein stenosis, or anatomical issues that prevent the use of the VasQ device may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the success rate and functionality of arteriovenous fistulas for dialysis patients, leading to better treatment outcomes.

How similar studies have performed: Previous studies on similar devices have shown promise, but the VasQ device represents a novel approach in this specific application.

Eligibility criteria

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.

Where this trial is running

Long Beach, California and 6 other locations

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

Study contacts

• Principal investigator: John F Lucas III, MD, FACS, FSVS — Greenwood Leflore Hospital
• Study coordinator: Galit Itzhaki

Conditions End Stage Renal Disease