Trial Outcomes & Findings for everlinQ endoAVF Post Market Study (NCT NCT02682420)

The everlinQ endoAVF Post Market Study began enrollment on September 20th 2016 and the last patient was enrolled on January 17th 2019.

everlinQ endoAVF Post Market Study

Primary patency was defined in this study as "The interval from the time of access placement until any intervention designed to maintain or re-establish patency, access thrombosis, access abandonment, or the time of measurement of patency".

Assisted Primary Patency was defined in this study as "The interval from access placement to thrombosis or abandonment; not triggered by access circuit interventions performed in the absence of occlusion".

Secondary Patency in this study was defined as "The interval from the time of access placement until access abandonment, loss to thrombosis, or the time of patency measurement including intervening manipulations (surgical or endovascular interventions) designed to re-establish functionality in thrombosed access".

Functional Patency in this study was defined as "The interval of time from the first 2-needle dialysis utilizing the access until access abandonment".

The time (number of days) from the index procedure (successful endoAVF creation) to the first use of the endoAVF. This endpoint is evaluated per participant rather than at specific time points.

The successful creation of an endoAVF with blood flow confirmed intraoperatively by fistulography or by duplex ultrasound postoperatively. This outcome measure is assessed at the time of the endoAVF creation.

The endoAVF-related interventions include: * Interventions to maintain or restore patency of the endoAVF, including endovascular and surgical procedures designed to address occlusive thrombosis (resulting in absence of thrill or bruit at endoAVF) and clinically significant occlusive stenosis at or near endoAVF site. * Interventions to support maturation of the arterialized vein segments, including endovascular procedures such as secondary coil embolization to facilitate flow into the target cannulation veins. * Interventions to support cannulation of the arterialized vein segments, including procedures such as a superficialization or elevation where the target cannulation vein is brought closer to the skin surface to enable cannulation, without the creation of a new AV fistula. * Any intervention to address any complications or adverse events of the access circuit. This outcome measure is assessed at the time of the endoAVF creation.

The endoAVF-related interventions include: * Interventions to maintain or restore patency of the endoAVF, including endovascular and surgical procedures designed to address occlusive thrombosis (resulting in absence of thrill or bruit at endoAVF) and clinically significant occlusive stenosis at or near endoAVF site. * Interventions to support maturation of the arterialized vein segments, including endovascular procedures such as secondary coil embolization to facilitate flow into the target cannulation veins. * Interventions to support cannulation of the arterialized vein segments, including procedures such as a superficialization or elevation where the target cannulation vein is brought closer to the skin surface to enable cannulation, without the creation of a new AV fistula. * Any intervention to address any complications or adverse events of the access circuit.

Total time from successful endoAVF creation to one of the following: * Successful hemodialysis using 2 needle cannulation OR * Vascular access that is free of stenosis or thrombosis, with brachial artery flow of at least 500 ml/min and at least a 4.0 mm vein diameter as measured via duplex ultrasound. Note: 63 participants completed the 6-month visit. Participants who did not receive a duplex ultrasound and have not yet successfully dialyzed using 2 needle cannulation are not counted for this endpoint.

Number of participants that were not on dialysis at endoAVF creation and are central venous catheter (CVC) free at indicated time points.

AE that: * led to death, * led to serious deterioration in the health of the patient, that either resulted in: a life-threatening illness or injury, or a permanent impairment of a body structure or a body function, or in-patient or prolonged hospitalization, or medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, * led to fetal distress, fetal death or a congenital abnormality or birth defect And has been determined by the CEC to be related to the everlinQ endoAVF System

AE that: * led to death, * led to serious deterioration in the health of the patient, that either resulted in: a life-threatening illness or injury, or a permanent impairment of a body structure or a body function, or in-patient or prolonged hospitalization, or medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, * led to fetal distress, fetal death or a congenital abnormality or birth defect And has been determined by the CEC to be related to the index procedure

This outcome measure references the participant's dialysis status throughout the study. Participants who began dialysis during the study and participants who were not on dialysis through the end of the study were not on dialysis at baseline.