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

Korábbi kezelés

• Known central venous stenosis or obstruction on the side of surgery.
• Expected kidney transplant within 12 months of enrollment.

Más betegség

• 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)
• Planned subsequent fistula superficialization procedure.
• Known coagulation disorder.
• Known allergy to nitinol.

Egyéb

• Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the VasQ.
• Pre-existing stents or stent grafts in the access circuit.
• 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.

• 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.