A Multicenter, Open Label, Prospective, Non-Randomized Study of the Incraft Stent Graft System in Subjects with Abdominal Aortic Aneurysms
ID Number 12-0762Principal Investigator(s)
Department(s) or Division(s)
The purpose of this clinical research study is to evaluate the safety and effectiveness of the INCRAFT™ Stent Graft system and its effectiveness in the treatment of abdominal aortic aneurysms. Patients that are considered good candidates for endovascular repair of the abdominal aortic aneurysm and placement of the INCRAFT™ device will be invited to participate.
An abdominal aortic aneurysm (abbreviated AAA) is a weakened/enlarged part of the largest blood vessel in the body, the aorta. The aorta carries blood pumped from the heart to the lower parts of the body, including the groin and legs. Because the vessel wall of the aorta is weak, the vessel has a high risk of rupturing in the aneurysm, causing one to bleed internally, often without warning. "Endovascular repair" refers to a catheter-based technology – a tube-like structure that is inserted into the body – that has the potential to reduce surgery-related risks (such as bleeding) and shorten hospital stays. Endovascular repair of AAA using the INCRAFT™ system involves the placement of a specially designed woven graft (fabric tubes) in the aorta. There are also special metal rings (stents) sewn to the graft that will help it stay in place. Each graft is enclosed in a small catheter (a long, flexible tube) that is inserted into the patient's aorta through the femoral artery in the his/her groin (at the top of his/her leg). Once the grafts are attached inside the patient's aorta, they work to reinforce the area of the aorta that is weakened and bulging from the aneurysm.
Recruiting Patients: Yes