A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access

Study Overview
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Brief Summary
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The CSP-2002 study will evaluate the safety and effectiveness of the InnAVasc arteriovenous graft (AVG) when implanted in and used for hemodialysis in participants suffering from end-stage renal failure (ESRD). The InnAVasc AVG is implanted and used similar to other standard-of-care dialysis grafts currently on the market. However, the InnAVasc AVG has been uniquely designed to potentially allow for immediate needle access (same day as implant surgery as opposed to 2-4 weeks of waiting), to potentially reduce excessive bleeding from the graft after dialysis, and it may provide protection from improper or missed needle cannulation attempts.

Detailed Description
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The InnAVasc AVG is intended for use in ESRD hemodialysis patients who require HD and whose next most appropriate access is an AVG, also including those who may require an immediate cannulation AVG. Patients with ESRD who require hemodialysis and are suitable for an AVG for hemodialysis access will be eligible for inclusion in the study. Subjects will be implanted with an InnAVasc AVG in the forearm or upper arm using standard vascular surgical techniques. The graft will be placed in a straight (soft C) configuration in the upper arm, or looped configuration in the forearm (forearm loop) or upper arm (axillary loop). Placing the graft across the elbow will be prohibited. Subjects must be able to be on antiplatelet therapy per the discretion of their physician (i.e., aspirin, clopidogrel, etc.).

Official Title
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A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease

Conditions
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End Stage Renal Disease (ESRD), Kidney Failure, Chronic Renal Disease

Intervention / Treatment
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* Device: InnAVasc arteriovenous graft surgical implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pre-operative Inclusion Criteria 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 commence antiplatelet therapy if the subject is not already taking (anticoagulation medication is acceptable if the subject is required to take an anticoagulant for a baseline medical condition), post graft implant; Able and willing to give informed consent; Anticipated life expectancy of at least 1 year. Intra-operative Inclusion Criteria 1. Both vessels have been exposed and are deemed appropriate for implantation (i.e., based on the surgeon's opinion, artery is of adequate size, has adequate pulse to support AV access flow, is without significant calcification, and is safely clampable; and the vein is of adequate size, free of localized sclerosis, and is free of immediate outflow obstruction). Exclusion Criteria: Patients will be excluded from the study for: 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, 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); Known or suspected central vein stenosis or obstruction on the side of planned graft implantation; Baseline hypotension or history of frequent hypotensive episodes during dialysis that, in the opinion of the investigator, puts the patient at increased risk of graft thrombosis; Uncontrolled hypertension, per the opinion of the investigator (i.e., recent history of recurrent hospitalizations for hypertensive related illness); Baseline hemoglobin <7 g/dL; Baseline platelet count <50,000 or >500,000 cells/mm3; Documented history of stroke within 6 months prior to enrollment; Treatment with any investigational drug or device within 30 days prior to enrollment; Female patients who are pregnant, intending to become pregnant, nursing or intending to breastfeed during the study (pregnancy test may only be omitted, if patient is post-menopausal or has a documented history of hysterectomy or permanent sterilization); History of cancer with active disease or treatment within the previous year, except for non-invasive basal or squamous cell carcinoma of the skin; Immunodeficiency including documented history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) or patients receiving immunosuppressive therapy for treatment of an acute inflammatory event or autoimmune flare. Chronic immunosuppressive therapy is acceptable; Documented or suspected hypercoagulable condition; Bleeding diathesis, other than that associated with ESRD; Documented history of heparin-induced thrombocytopenia (HIT); Active local or systemic infection as documented from the medical history or bloodwork / blood culture data. If the infection resolves, the subject must be at least one-week post resolution of that infection before implantation; Scheduled renal transplant within 6 months; Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and effectiveness of the InnAVasc AVG; Patient is unable or unwilling to complete all required follow-up assessments and questionnaires. Exclusion Criteria: Pre-operative Exclusion Criteria: Patients will be excluded from the study for: 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, 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); Known or suspected central vein stenosis or obstruction on the side of planned graft implantation; Baseline hypotension or history of frequent hypotensive episodes during dialysis that, in the opinion of the investigator, puts the patient at increased risk of graft thrombosis; Uncontrolled hypertension, per the opinion of the investigator (i.e., recent history of recurrent hospitalizations for hypertensive related illness); Baseline hemoglobin <7 g/dL;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: A prospective, multi-center, single-arm study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: InnAVasc AVG treatment<br>Patients will be surgically implanted with an InnAVasc AVG in the forearm or upper arm using standard vascular surgical techniques. The graft will be placed in a straight (soft C) configuration in the upper arm, or looped configuration in the forearm (forearm loop) or upper arm (axillary loop). | Device: InnAVasc arteriovenous graft surgical implant<br>* The InnAVasc AVG is a hemodialysis vascular access graft, intended for implantation in the lower or upper arm using standard vascular techniques, in patients requiring hemodialysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary patency of study device at 6 months | This is the Primary Effectiveness Endpoint Outcome for the study. This outcome is measured as the proportion of subjects with secondary patency (i.e. not abandoned) at 6 months. | 6 months | 
| Incidence of adverse events of special interest related to InnAVasc AVG [Time Frame: through 6 months] | This is the Primary Safety Outcome in the study. Incidence of adverse events of special interest (device-related AESIs) are adverse events that are most clinically relevant to hemodialysis access. AESIS are as follows: Infection of the study graft; Pseudoaneurysm formation at any point a long 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); Bleeding from the study graft requiring surgical or endovascular intervention or ≥ 2-unit blood transfusion; Hematoma from the study graft requiring surgical or endovascular intervention; Seroma of the study graft requiring surgical or endovascular intervention; Thrombosis of the study graft. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful cannulation | Proportion of subjects achieving successful cannulation on or before day 7, defined as the first 2-needle dialysis session through the study graft | 7 days | 
| Sustained use | Proportion of subjects achieving sustained use of 3 months,6, months, 12 months, 18 months, and 24 months. | 3, 6, 12, 18 and 24 months |