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Clinical Trial Details

Title
A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de novo Native Coronary Artery Lesion (ABSORB III)
Study Purpose
The pivotal trial to support the US pre-market approval (PMA) of Absorb BVS. ABSORB III will evaluate the safety and effectiveness of the Absorb BVS System compared to the XIENCE in the treatment of subjects, including those with diabetes mellitus, with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.
Study Plan
Subjects will be randomized to treatment with the study device or an FDA approved stent.
Investigators

Principal Investigator
Theodore A. Bass, M.D.
Medicine

Sub Investigator
Dominick J. Angiolillo, M.D., Ph.D., FACC
Medicine

Sub Investigator
Martin "M" Zenni, M.D.
Medicine

Meeting Schedule & Submission Deadlines

Note: All submissions for IRB review require a single electronic copy of all documents to be emailed and a single (signed) original hardcopy be provided to the IRB office. The IRB cannot log in the submission until the paper copy is received.

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