Clinical Evaluation of a Vascular Venous Anastomotic Connector

Summary

Participation Requirements

Description

The InterGraft™ Venous Anastomotic Connector (VIG) was developed for minimally invasive venous anastomosis of a standard hemodialysis graft. This study will evaluate the safety and performance of the VIG for anastomosis of a commercially available, 6 mm diameter, ePTFE hemodialysis graft. Anastomose...

The InterGraft™ Venous Anastomotic Connector (VIG) was developed for minimally invasive venous anastomosis of a standard hemodialysis graft. This study will evaluate the safety and performance of the VIG for anastomosis of a commercially available, 6 mm diameter, ePTFE hemodialysis graft. Anastomoses with the VIG may potentially reduce venous vessel trauma, improve the local vessel wall shear stresses and promote laminar flow, thereby improving patency. The available InterGraft™ Arterial Anastomotic Connector (AIG) will also be used during the study in a subgroup of suitably qualified subjects for purposes of additional data collection. While recognizing that a native fistula is the recommended access for hemodialysis, AV grafts 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 AV graft, as determined by the physician. The graft implant procedural outcomes, the number and type of major adverse events, and patency throughout a six (6) month follow-up period will be evaluated. The 6-month patency rate will be compared with a pre-specified patency performance goal that is drawn from prior surgical AV graft literature and published performance standards.10, 14-20 The study will be conducted in compliance with the Investigational Plan, Investigational Device Exemption (IDE) regulations, Good Clinical Practice guidelines (GCP), and other applicable regulatory requirements. This is a pivotal multicenter, prospective, non-randomized adaptive design study. The planned study enrollment is 104 evaluable subjects who require AV graft placement for hemodialysis and who meet the entry criteria. The subjects will receive the VIG device and will have either a standard sutured arterial anastomosis or have received an AIG device for the arterial anastomosis (VIG-AIG subgroup). This number may be expanded following a planned interim analysis to up to 185 evaluable subjects for the primary study evaluation. The study will allow for a maximum enrollment of 227 subjects, including a provision for 12 subjects lost to follow-up and up to 30 roll-in cases. Roll-in subjects will not be included in the primary analysis but will be analyzed separately. The study will include up to 15 participating clinical centers. Study site investigators will be physicians skilled in AV access graft placement and interventional techniques. Study data will be collected up to the point at which each subject has completed the 6-month endpoint. VIG-AIG Subgroup All study subjects will receive the VIG device. A subgroup of previously enrolled subjects receiving the VIG device will also have received an AIG device for the arterial anastomosis, rather than a sutured arterial anastomosis. This group is referred to as the "VIG-AIG Subgroup."

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