U.S. Pivotal Trial
The Food and Drug Administration (FDA) has granted approval to Aptus Endosystems to conduct a clinical trial with the Aptus™ Endovascular AAA Repair System. The STAPLE-1 Feasibility Trial was successfully completed at 6 centers in the U.S. The objective of this study was to evaluate the safety and technical feasibility of the Aptus™ Endovascular AAA Repair System for treatment of infrarenal abdominal aortic and aorto-iliac aneurysms.
In September 2007, the STAPLE-2 Pivotal Trial was initiated to study the safety and effectiveness of the Aptus™ Endovascular AAA Repair System. This study is being conducted at up to 25 clinical institutions across the United States.
Participating Centers
| 1 | Albany Medical Center Albany, New York Manish Mehta, MD (518) 262-6089 |
2 | Southern Illinois University School of Medicine Springfield, IL Kim J. Hodgson, MD (217) 545-8856 |
3 | University of Alabama School of Medicine Birmingham, AL William Jordan, Jr., MD (205) 934-7279 |
| 4 | Georgetown University Hospital Washington, DC Joseph Babrowicz, MD (202) 444-1265 |
5 | Greenville Memorial Hospital Greenville, SC Bruce Gray, DO (864) 455-6800 |
6 | Duke University Medical Center Durham, NC Richard McCann, MD (919) 681-1093 |
| 7 | Emory University Atlanta, GA Elliot Chaikof, MD, PhD (407) 727-8413 |
8 | Mount Sinai School of Medicine New York, NY Alfio Carroccio, MD (212) 241-5393 |
9 | Oklahoma Heart Hospital Oklahoma City, OK Jim G. Melton, DO (405) 608-3800 |
| 10 | Riverside Methodist Hospital Columbus, OH Charles Botti, Jr., MD (614) 263-1011 |
11 | Vascular & Transplant Specialists Norfolk, VA Marc Glickman, MD (757) 622-2649 |
12 | Vanderbilt University Medical Center Nashville, TN Thomas C. Naslund, MD (615) 322-2343 |
| 13 | University of South Florida Tampa, FL Martin Back, MD (813) 259-0956 |
14 | NYU School of Medicine New York, NY Mark Adelman, MD (212) 263-7311 |
15 | Mayo Clinic Hospital Scottsdale, AZ Richard Fowl, MD (480) 342-2868 |
| 16 | Minneapolis Vascular Physicians Plymouth, MN Bill McMillan, MD (763) 398-8710 |
17 | Hospital of the University of Pennsylvania Philadelphia, PA Ronald Fairman, MD (215) 614-0243 |
18 | Montefiore Medical Center Bronx, NY Evan Lipsitz, MD (718) 920-2016 |
| 19 | St. Luke’s Episcopal Hospital Houston, TX Zvonimir Krajcer, MD (713) 790-9410 |
20 | Carolina Vascular Asheville, NC John Henretta, MD (828) 213-9115 |
21 | Cleveland Clinic Foundation Cleveland, OH Daniel Clair, MD (216) 444-9531 |
| 22 | University of Medicine & Dentistry of New Jersey Newark, NJ Alan Graham, MD (732) 235-8142 |
23 | Dartmouth-Hitchcock Medical Center Lebanon, NH Mark Fillinger, MD (603) 650-6379 |
24 | Massachusetts General Hospital Boston, MA Christopher Kwolek, MD (617) 724-6101 |
Caution — Investigational device. Limited by Federal (or United States) law to investigational use.