BEACH Trial: Bovine Early Access, Compatibility and Hemostasis Trial
Condition: Renal Insufficiency,Chronic
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic
Intervention: Artegraft® Collagen Vascular Graft™ (Artegraft)
Intervention description: The Artegraft is intended for use distal to the aorta as a segmental arterial replacement, as an arterial bypass, as an arteriovenous shunt where more conventional methods have proven inadequate, or as an arterial patch graft.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Artegraft will follow all study patients enrolled in the proposed clinical trial and that have successful cannulation within 72 hours as defined above, for 6 months. If follow-up is necessary at 1 year after graft implantation, it will be done via phone survey. The late-access group [>/= 10 days] will be followed to 30 days post-first cannulation. If follow-up is necessary at 6 months after graft implantation, it will be done via phone survey. Day 0 is defined as the day of first cannulation, for early-access and late-access groups, to allow full follow-up to at least 30 days for both groups.
Masking: Single (Investigator)
Masking description: Patients will be randomized in a 2:1 ratio to either early or late vascular access. The randomization will be stratified by investigative site, and will use a random permuted block design within strata, with blocks of size 3 and 6 ordered randomly within site.
Once a patient signs informed consent, is determined to meet the inclusion/exclusion criteria, and is successfully implanted with the Artegraft, the site designated staff will open an envelope to determine the randomization number and whether the patient is randomly allocated to early or late vascular access.
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Bovine Early Access, Compatibility, and Hemostasis (BEACH) Trial Study is to evaluate the
      Safety and Effectiveness of Early Access in Patients Who Require an Arteriovenous Conduit for
      Hemodialysis using the Artegraft® Collagen Vascular Graft™. The objective of the BEACH Trial
      is to demonstrate that early access of Artegraft is associated with acceptable rates of
      successful early access, and acceptable rates of a composite of adverse events, to support a
      modification of existing device labeling stating that Artegraft is capable of cannulation
      within 72 hours post implantation.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients are eligible to be included in the study only if they meet the following criteria:

          1. Male or Female, 18 years or older

          2. Diagnosis of End Stage Renal Disease (ESRD) and require vascular access for
             hemodialysis

          3. Native [autogenous tissue] AV fistula creation or access is not indicated or
             non-viable [disadvantaged veins]

          4. Requiring repair of an existing fistula or conduit, but only if using Artegraft as an
             interposition placement and the Artegraft is cannulated [not the fistula]. Artegraft
             must be place in a fresh subcutaneous tunnel. Thigh loop grafts will not be used.

          5. Able to accommodate vascular graft placement in the upper extremity (i.e., forearm, or
             upper arm)

          6. Capable of giving signed informed consent, which includes compliance with the
             requirements and restrictions listed in the informed consent form (ICF)

          7. Able and willing to comply with the study protocol

          8. Agrees to initiate and maintain hemodialysis treatments

          9. Life expectancy is > 1 year based on physician assessment

        Exclusion Criteria:

        Patients are excluded from the trial if any of the following criteria apply:

          1. High grade central venous stenosis/occlusion

          2. Breast-feeding, pregnant or planning pregnancy within next 12 months.

          3. Non-resolved infected existing grafts

          4. Documented sepsis/bacteremia by blood culture within 4 weeks of implantation.

          5. History of non-controlled immunodeficiency syndrome, including AIDS/HIV; Active
             clinically significant immune-mediated disease, not controlled by low-dose maintenance
             immunosuppression. The diagnosis of HIV alone, provided adequately treated, is not a
             contraindication for enrolment.

          6. Severe liver dysfunction and/or coagulation or bleeding disorders.

          7. Elevated platelet count > 1 million cells/mm3

          8. History of heparin-induced thrombocytopenia syndrome (HIT)

          9. Documented hypercoagulable state

         10. Currently participating in another investigational drug or device study which may
             clinically interfere with any endpoints of this trial

         11. Known hypersensitivity or contraindication to device materials or procedural
             medications that cannot be adequately managed medically

         12. History or evidence of severe cardiac disease (NYHA Functional Class III or IV), ,
             myocardial infarction within 6 months of enrollment, ventricular tachyarrhythmias
             requiring continuing treatment, or unstable angina, uncontrolled CHF

         13. History or evidence of severe peripheral arterial disease in the extremity selected
             for implant (i.e. arterial inflow insufficient to support hemodialysis)

         14. History of cancer with active disease or treatment within the previous year, except
             for non-invasive basal or squamous cell carcinoma of the skin

         15. Bleeding diathesis, other than that associated with ESRD

         16. Scheduled renal transplant within 6 months

         17. Patients who require chronic anticoagulation except for antiplatelet therapy. Patients
             currently receiving or who have received within the last month direct thrombin
             inhibitors, factor Xa inhibitors, or vitamin K antagonists should not be included in
             the study.