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BEACH Trial: Bovine Early Access, Compatibility and Hemostasis Trial

Artegraft, Inc. · 2019
ClinicalTrials.gov · Datasets · License: Public Domain · 2019
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chronicrenal-insufficiency
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.
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