Clinical Evaluation of a Vascular Venous Anastomotic Connector [InterGraft VIG-only Study]

Inclusion criteria

• ✓. Subject is ≥ 18 years of age.
• ✓. Subject requires the creation of a vascular access graft for hemodialysis, secondary to a diagnosis of End Stage Renal Disease.
• ✓. Subject is able to have the vascular access graft placed in an upper extremity.
• ✓. Baseline imaging shows suitable vascular anatomy/ vessel size for the InterGraft™ Venous Connector and an artery at least 3.5 mm in diameter that is suitable for creating the arterial anastomosis.
• ✓. Subject has a reasonable expectation of remaining on hemodialysis for at least 6 months.
• ✓. Subject or his/her legal guardian understands the study and is willing and able to comply with the dialysis schedule and follow-up requirements.
• ✓. Subject or his/her legal guardian provides written informed consent. NOTE: In accordance with the requirements of some Institutional Review Boards, where applicable, only those subjects with capacity to consent for themselves will be included. Thus, where required by the Institutional Review Board, adult individuals who lack capacity to consent for themselves will be excluded from the study.
• ✓. Physician's examination at time of surgery shows no significant vessel lesions, calcification(s), anatomic structures or abnormalities that may limit ability to safely deploy the InterGraft Connectors or create a sutured arterial anastomosis.