Early report from an investigator-initiated investigational device exemption clinical trial on physician-modified endovascular grafts

• Published in: Journal of vascular surgery Vol. 58; no. 2; pp. 311 - 317
• Main Authors: Starnes, Benjamin Ware, MD, Tatum, Billi, RN, CRCC
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.08.2013
• Subjects: Aged; Aged, 80 and over; Aortic Aneurysm, Abdominal - diagnosis; Aortic Aneurysm, Abdominal - mortality; Aortic Aneurysm, Abdominal - surgery; Aortography - methods; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation - adverse effects; Blood Vessel Prosthesis Implantation - instrumentation; Blood Vessel Prosthesis Implantation - mortality; Endovascular Procedures - adverse effects; Endovascular Procedures - instrumentation; Endovascular Procedures - mortality; Female; Hospital Mortality; Humans; Male; Middle Aged; Postoperative Complications - mortality; Postoperative Complications - therapy; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Stents; Surgery; Time Factors; Tomography, X-Ray Computed; Treatment Outcome; Ultrasonography, Doppler, Duplex; Washington; Washington

Objective To determine whether a physician-modified endovascular graft (PMEG) is a safe and effective method for treating patients with juxtarenal aortic aneurysms who are deemed unsuitable for open repair. Methods A nonrandomized, prospective, consecutively enrolling investigational device exemptio...