BEACH Trial: Bovine Early Access, Compatibility and Hemostasis Trial

Stopped early · Phase 3

Conditions studied: Renal Insufficiency,Chronic

In brief

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.

Key facts

Study ID

NCT04146012

Run by

Artegraft, Inc.

People needed

50

Starts

2019-12-03

Expected to finish

2020-06-16

Last updated by the study team

2023-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients are eligible to be included in the study only if they meet the following criteria:
• Male or Female, 18 years or older
• Diagnosis of End Stage Renal Disease (ESRD) and require vascular access for hemodialysis
• Native [autogenous tissue] AV fistula creation or access is not indicated or non-viable [disadvantaged veins]
• 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.
• Able to accommodate vascular graft placement in the upper extremity (i.e., forearm, or upper arm)
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF)
• Able and willing to comply with the study protocol
• Agrees to initiate and maintain hemodialysis treatments
• Life expectancy is > 1 year based on physician assessment

You may not qualify if…

• Patients are excluded from the trial if any of the following criteria apply:
• High grade central venous stenosis/occlusion
• Breast-feeding, pregnant or planning pregnancy within next 12 months.
• Non-resolved infected existing grafts
• Documented sepsis/bacteremia by blood culture within 4 weeks of implantation.
• 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.
• Severe liver dysfunction and/or coagulation or bleeding disorders.
• Elevated platelet count > 1 million cells/mm3
• History of heparin-induced thrombocytopenia syndrome (HIT)
• Documented hypercoagulable state
• Currently participating in another investigational drug or device study which may clinically interfere with any endpoints of this trial
• Known hypersensitivity or contraindication to device materials or procedural medications that cannot be adequately managed medically
• 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
• History or evidence of severe peripheral arterial disease in the extremity selected for implant (i.e. arterial inflow insufficient to support hemodialysis)
• History of cancer with active disease or treatment within the previous year, except for non-invasive basal or squamous cell carcinoma of the skin
• Bleeding diathesis, other than that associated with ESRD
• Scheduled renal transplant within 6 months
• 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.

Where it is running

• University of California — San Diego, California, United States
• Capital District Renal Physicians — Albany, New York, United States
• Dialysis Access Institute — Orangeburg, South Carolina, United States
• Spartanburg Regional Medical Center — Spartanburg, South Carolina, United States
• City Hospital at White Rock — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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