The goal of the CSP-2002 clinical trial is to evaluate the safety and effectiveness of the InnAVasc Arteriovenous Graft (IG) for hemodialysis (HD) access in patients with end-stage renal disease (ESRD). The primary study endpoints are:
Primary Effectiveness Endpoint: The proportion of subjects with secondary patency at 6 months.
Primary Safety Endpoint: The incidence of device-related adverse events of special interest (AESIs) through 6 months.
Participants will be asked to sign an informed consent form. Once enrolled, they will be assessed to receive the study graft implant and asked to participate in periodic follow-up visits and assessments through 2 years following implant.
Patients with ESRD whose next most appropriate option for AV access is placement of an AV graft to start or maintain hemodialysis therapy;
Age 18 to 90 years old, inclusive;
Suitable anatomy for implantation of upper arm "straight" or looped graft, or forearm looped graft (graft not to cross the bend of the elbow);
Ability to continue or commence antiplatelet therapy post graft implant (anticoagulation medication is acceptable if the subject is required to take an anticoagulant for a baseline medical condition);
History or evidence of severe cardiac disease (i.e., debilitating heart failure, or high risk of MI) in the opinion of the investigator which may preclude participation in and completion of the study;
Uncontrolled diabetes in the opinion of the investigator (i.e., multiple recent diabetes related hospitalizations);
For upper arm straight configuration, an antecubital fossa crease to axillary crease distance < 18 cm;
History or evidence of severe peripheral arterial disease in the extremity selected for implant (i.e., arterial inflow insufficient to support hemodialysis access);
Single group
InnAVasc Arteriovenous Graft (IG) surgical implant
DeviceThe InnAVasc Arteriovenous Graft (IG) is a hemodialysis vascular access graft, intended for implantation in the lower or upper arm using standard vascular techniques, in patients requiring hemodialysis
Secondary patency of study device at 6 months
The primary effectiveness endpoint is defined as the proportion of subjects with secondary patency at 6 months.
Incidence of adverse events of special interest related to InnAVasc AVG [Time Frame: through 6 months]
The primary safety endpoint is the incidence of device-related adverse events of special interest (AESIs) through 6 months, defined as: 1. Infection of the study graft; 2. Pseudoaneurysm formation at any point along the study graft requiring surgical or endovascular intervention (pseudoaneurysms that occur at sites of needle cannulation, but which are small enough to be observed without intervention, do not trigger this element of the AESI endpoint); 3. Bleeding from the study graft requiring surgical or endovascular intervention or ≥2-unit blood transfusion; 4. Hematoma from the study graft requiring surgical or endovascular intervention; 5. Seroma of the study graft requiring surgical or endovascular intervention;
Successful cannulation on or before Postoperative Day 7
Proportion of subjects achieving successful cannulation on or before Day 7, defined as the first 2-needle dialysis session through the study graft
Sustained use
Proportion of subjects achieving sustained use of 3 months, 6, months, 12 months, 18 months and 24 months. Sustained use is a period of time in which the study graft is used for consecutive dialysis sessions without the requirement for alternative hemodialysis vascular access to be used as a route to receive renal replacement therapy. A sustained use period can be achieved at any time throughout the study period of 24 months.
Primary Patency Rate
Exploratory endpoint 1: Time from creation of access to first intervention to maintain patency or thrombosis
Assisted Primary Patency Rate
Exploratory endpoint 2: Time from creation of access to first thrombosis, irrespective of intervention to maintain patency.
Secondary Patency Rate
Exploratory endpoint 3: Time from creation of access to study graft abandonment or achievement of a censored event (death, transfer to peritoneal dialysis, renal transplant, steal, venous hypertension, or end of study period), and includes all surgical and endovascular interventions to reestablish study graft patency.
Thrombosis rate per patient
Exploratory endpoint 4: The per patient rate of thrombosis events of the study graft at a particular timepoint.
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