Zenith p-Branch Pivotal Study

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Brief description of study

This clinical investigation is intended to evaluate the safety and effectiveness of the Zenith® p-Branch™ in combination with Atrium iCAST™ covered stents for the treatment of pararenal or juxtarenal aortic aneurysms. The primary safety and effectiveness endpoint is treatment success at 12 months. This prospective, non-randomized, multicenter clinical investigation will enroll up to 82 patients to receive the Zenith® p-Branch™ at up to 30 clinical sites (maximum of 20 patients per site). Patient enrollment is expected to be completed within 2.5 years of study initiation. Follow-up data will be collected for 5 years post-procedure

Clinical Study Identifier: s15-00404

ClinicalTrials.gov Identifier: NCT02396199

Principal Investigator: Thomas Maldonado.

Other Investigators: Patrick J Lamparello, Mikel Sadek, Joanelle Z. Lugo, Glenn R Jacobowitz, Neal S Cayne, Todd L. Berland, Caron B Rockman.

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