The InterGraft™ Venous Anastomotic Connector provides an endovascular, minimally invasive means for attachment of an arteriovenous graft to a vein in the upper extremity. The InterGraft™ Venous Anastomotic Connector facilitates creation of the arteriovenous graft connection to a vein in support of hemodialysis in subjects with End Stage Renal Disease. The InterGraft™ Venous Anastomotic Connector is used together with conventional suturing of the arterial anastomosis to facilitate creation of an arteriovenous graft in support of hemodialysis in subjects with End Stage Renal Disease.
The InterGraft™ Venous Anastomotic Connector (VIG) was developed for endovascular, minimally invasive venous anastomosis of a standard arteriovenous graft (AVG) for hemodialysis. This study will evaluate the safety and performance of the VIG for anastomosis of a commercially available, 6 mm diameter, synthetic AVG. Anastomoses with the VIG may potentially reduce venous vessel trauma, improve the local vessel wall shear stresses and promote laminar flow, thereby improving patency. While recognizing that a native fistula is the recommended access for hemodialysis, AVGs remain a frequently used access type. This study focuses on subjects who have a failed fistula, cannot have a fistula or are better suited for an AVG, as determined by the physician. The implant procedural outcomes, the number and type of major adverse events, and patency throughout a six-month follow-up period will be evaluated. The six-month patency rate will be compared with a pre-specified patency performance goal drawn from surgical AVG literature and published performance standards. This is a pivotal, multicenter, prospective, non-randomized design study. All enrolled subjects will receive the VIG device and will have a standard sutured arterial anastomosis. A total of 158 evaluable subjects will be enrolled, defined as primary analysis population of 146 subjects plus allowance for 12 subjects lost-to-follow up. The study includes10 participating clinical centers. Study site investigators are physicians skilled in AVG placement and interventional techniques. Study data will be collected up to the point at which each subject has completed the six-month endpoint or experienced a terminal study endpoint. The study will be conducted in compliance with the Investigational Plan, Investigational Device Exemption regulations, Good Clinical Practice guidelines, and other applicable regulatory requirements.
Study Type
INTERVENTIONAL
Allocation
The device is designed for transcatheter delivery within a vein and connection to an AVG that has been tunneled under the skin in a standard manner. The connection is made via a small skin incision.
The arterial anastomosis of the implanted vascular graft for hemodialysis is formed using standard suturing technique.
The implanted vascular graft is intended as a vascular access for performing hemodialysis treatments.
Triad of Alabama/Flowers Hospital
Dothan, Alabama, United States
Cartersville Medical Center, LLC
Cartersville, Georgia, United States
Medical Center of Central Georgia - Navicent Health
Macon, Georgia, United States
Cumulative Patency at 6 Months
Percentage of subjects free from loss of access of the study graft for hemodialysis
Time frame: Six months of clinical follow-up following treatment assignment (enrollment)
Acute Device Success
AV graft flow at end of implant procedure
Time frame: 24 hours
Primary Unassisted Patency
Percentage of subjects free from the occurrence of either access thrombosis or an access procedure performed to maintain access patency
Time frame: Six months
Time to First Cannulation
Time from initial access placement to first graft cannulation for hemodialysis
Time frame: Six months
Interventions Required to Maintain Patency
Number of interventions required to maintain secondary patency
Time frame: Six months
Serious Adverse Events (Secondary Endpoint Defined SAEs)
Number and type of serious adverse events- death, emergent surgery, significant bleeding,graft infection, pseudoaneurysm
Time frame: Six months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
158
Henry Ford Health System- Dept of Surgery
Detroit, Michigan, United States
Saint Louis University
St Louis, Missouri, United States
Surgical Specialists of Charlotte
Charlotte, North Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
McLeod Physician Associates II
Florence, South Carolina, United States
Regional Medical Center of Orangeburg and Calhoun Counties
Orangeburg, South Carolina, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States