Enrollment starts for STAPLE-2 trial
Drs Michael G Douglas and John P Henretta, of Carolina Vascular, a division of Asheville Radiology, have performed the first procedure as part of the multicenter STAPLE-2 Clinical Trial to assess the safety and effectiveness of the Aptus Endovascular AAA Repair System (Aptus Endosystems). The Aptus Endograft and EndoStapling System, which together form a novel and promising new technology platform for the minimally invasive repair of abdominal aortic aneurysms (AAA), were successfully deployed in a procedure. The patient is the first of up to 135 patients slated for enrollment in the pivotal phase of Aptus Endosystems’ clinical study, being conducted at up to 25 medical institutions in the US. The company recently completed its STAPLE- 1 Feasibility Study, successfully enrolling 21 patients at five US medical centers, and designed to demonstrate the safety and feasibility of the system. The STAPLE-2 Clinical Trial is lead by Drs Ronald Fairman of the Hospital of the University of Pennsylvania and Manish Mehta of the Albany Medical Center as co- National Principal Investigators. The current endograft system is the first to be attached to the aorta with individual EndoStaples that reproduce the suture fixation used in open surgical repair of AAA. The capability to deliver these EndoStaples independent of endograft deployment, and at selected sites within the vessel, makes it possible to provide a much smaller delivery system for the endograft itself. It also secures the endograft in place in a manner that emulates the way grafts are secured in open surgical repair that has proven longterm results. “Secure fixation with the ability to place the device precisely where you want it … it mimics open surgery,” commented Douglas. “I left the case feeling that I provided my patient with a very good and durable result,” added Henretta, site Principal Investigator for the Asheville group. “We are privileged to have two vascular surgeons with such extensive clinical experience in endovascular aneurysm repair leading this very important clinical study,” noted Bob H Katz, President of Aptus Endosystems.