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

Description

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.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 wil

Trial Eligibility

Inclusion Criteria: Pre-operative Inclusion Criteria 1. Patients with ESRD whose next most appropriate option for AV access is placement of an AV graft to start or maintain hemodialysis therapy; 2. Age 18 to 90 years old, inclusive; 3. Suitable anatomy for implantation of upper arm "straight" or looped graft, or forearm looped graft (graft not to cross the bend of the elbow); 4. 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; 5. Able and willing to give informed consent; 6. 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: 1. 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; 2. Uncontrolled diabetes in the opinion of the investigator (i.e., multiple recent diabetes related hospitalizations); 3. For upper arm straight configuration, antecubital fossa crease to axillary crease distance \< 18 cm; 4. History or evidence of severe peripheral arterial disease in the extremity selected for implant (i.e., arterial inflow insufficient to support hemodialysis access); 5. Known or suspected central vein stenosis or obstruction on the side of planned graft implantation; 6. 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; 7. Uncontrolled hypertension, per the opinion of the investigator (i.e., recent history of recurrent hospitalizations for hypertensive related illness); 8. Baseline hemoglobin \<7 g/dL; 9. Baseline platelet count \<50,000 or \>500,000 cells/mm3; 10. Documented history of stroke within 6 months prior to enrollment; 11. Treatment with any investigational drug or device within 30 days prior to enrollment; 12. 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); 13. History of cancer with active disease or treatment within the previous year, except for non-invasive basal or squamous cell carcinoma of the skin; 14. 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; 15. Documented or suspected hypercoagulable condition; 16. Bleeding diathesis, other than that associated with ESRD; 17. Documented history of heparin-induced thrombocytopenia (HIT); 18. 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; 19. Scheduled renal transplant within 6 months; 20. Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and effectiveness of the InnAVasc AVG; 21. 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: 1. 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; 2. Uncontrolled diabetes in the opinion of the investigator (i.e., multiple recent diabetes related hospitalizations); 3. For upper arm straight configuration, antecubital fossa crease to axillary crease distance \< 18 cm; 4. History or evidence of severe peripheral arterial disease in the extremity selected for implant (i.e., arterial inflow insufficient to support hemodialysis access); 5. Known or suspected central vein stenosis or obstruction on the side of planned graft implantation; 6. 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; 7. Uncontrolled hypertension, per the opinion of the investigator (i.e., recent history of recurrent hospitalizations for hypertensive related illness); 8. Baseline hemoglobin \<7 g/dL;

Study Info

Interventions

Locations Recruiting

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