BEACH Trial: Bovine Early Access, Compatibility and Hemostasis Trial
BEACH Trial: Bovine Early Access, Compatibility and Hemostasis Trial
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.
Chronic kidney disease (CKD) is a major health problem that affects approximately 26 million
 Americans. Many of those suffering CKD will progress to develop end stage renal disease
 (ESRD) and require lifelong hemodialysis (HD) to filter wastes from their blood. There are
 nearly 2.5 million patients who receive HD worldwide, and this population is growing at a
 rate of 8% per year. This projects that the worldwide HD population to reach approximately
 3.4 million by the year 2020. There are over 600,000 patients on HD in the US and an
 estimated 100,000 new cases are reported annually. The interventions required to maintain a
 person on HD carry a significant financial burden, with costs estimated to be as high as $30
 billion annually. Given the increasing epidemic of obesity, diabetes, and heart disease, the
 burden of ESRD will continue to grow, making new interventions that can improve the social,
 physical, and financial realities of treating ESRD essential.

 A critical factor in the survival of renal dialysis patients is the surgical creation of
 vascular access. Despite the fistula-first initiative, many patients will start hemodialysis
 using a central venous catheter (CVC). This increases the risks of associated bloodstream
 infections, central venous stenosis, and poorer outcomes from subsequent vascular
 cannulations.

 Arteriovenous grafts have advantages compared with central venous catheters for dialysis and
 guidelines suggest their use as second choice after arteriovenous fistulas. The suggested
 advantages of grafts over fistulas is the ability to cannulate or access the graft earlier,
 traditionally 2 weeks for AVG rather than 6 weeks for AVF, and the lower rates of primary
 failure.

 Standard practice with expanded polytetrafluoroethylene (ePTFE) grafts has been to avoid
 cannulation for 2 weeks following placement, but new generation grafts have been marketed for
 their early cannulation properties allowing use as an alternative to central venous catheters
 for prompt access.

 The proposed BEACH Trial is a multi-center, prospective clinical trial to evaluate early
 access of an existing, FDA-approved bovine carotid vascular graft, approved as a general
 peripheral vascular graft and for hemodialysis. The BEACH Trial is seeking to demonstrate
 that early access, defined as within 72 hours post implantation, of the Artegraft device
 results in acceptable clinical outcomes including ability to support dialysis needs thereby
 obviating the requirement for interim catheter placement or facilitating the removal of an
 existing catheter with acceptable composite major adverse clinical events (MACE) rate up to
 26 weeks (6 months) post implant.

 Few vascular products approved in the 1970s have a broad level of acceptance in today's
 competitive market. Review of the original NDA application for Artegraft as well as the
 scientific literature revealed no clinical rationale for a waiting period of 14 days (for
 most access grafts) and 10 days (for Artegraft) before cannulation. The current literature
 does not seem to support the current guidelines as there is no evidence to suggest that a
 delay in cannulation of PTFE grafts will improve graft survival and patency.Note also that
 Artegraft cannot identify any scientific justification in the original NDA for the warning
 that was placed in the IFU to support the 10-day waiting period before cannulation.

 Further, if it is assumed that dialysis is conducted 3 times per week, by allowing
 cannulation to the Artegraft device in the 72-hour period, only 6 to 10 additional needle
 punctures are added during the first 10-day period depending on whether cannulation is
 initiated within 72 hours, respectively. Artegraft believes that this limited number of
 additional early needle punctures will not significantly affect the safety or efficacy of the
 graft or the cannulation procedure.
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.