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

Launched by LAMINATE MEDICAL TECHNOLOGIES · Jul 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device called VasQ, which is designed to support a type of surgical connection known as an arteriovenous fistula. This connection is often created for patients with end-stage renal disease who need dialysis. The trial will compare two groups: one group will have the VasQ support during their fistula surgery, and the other group will receive standard care without the VasQ support. The researchers hope to learn if using VasQ helps improve the success of these surgeries.

To participate in this study, individuals must be between 18 and 80 years old and have a need for a new surgical fistula for dialysis access. They should be able to attend follow-up visits over the next year and provide their consent to participate. However, certain patients may not be eligible, such as those with existing vein problems or other health issues that could affect the study results. Participants will be monitored closely for 12 months to see how well the surgery works with or without the VasQ device. This trial is currently recruiting patients, and anyone interested should discuss with their doctor to see if they qualify.

Gender

ALL

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.