Zenith p-Branch Pivotal Study

Brief description of study

The purpose of this study is to assess the safety of the Zenith® p-Branch® and how well it works in combination with Atrium iCAST™ covered stents (mesh tube) to improve blood flow to your organs and legs. The Zenith® p-Branch™ is an investigational device because it is not approved by the Food and Drug Administration (FDA) and the Atrium iCAST™ is a FDA approved device. An endovascular graft is a (tube) made of polyester fabric sewn to a metal mesh (stent). The Zenith® p-Branch® device is a endovascular graft system that is used in combination with Atrium iCAST™ covered stents to treat bulges or aneurysms in the abdominal aorta (the largest artery in your abdomen). If your bulge extends further down your aorta and your doctor determines that is appropriate, an additional component, the Zenith® Universal Distal Body Endovascular Device may be used with the Zenith® p-Branch® as well. The Zenith® Universal Distal Body Endovascular Device like the Zenith® p-Branch® has not been approved by the FDA. Atrium iCAST™ covered stents are FDA approved,. However, the use of this device in combination with the Zenith® p-Branch® is not FDA approved.


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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