Condition: Technical Sucess · Freedom From Type I and III Endoleaks at 12 Months · Freedom From Stent Graft Migration at 12 Months · Sponsor: Baystate Medical Center
Patients who are found to have an aneurysm (bulge) in the abdominal aorta, which is the blood vessel in your abdomen (belly) that supplies blood to most of your lower body, including major organs and your legs. As an aneurysm expands, the walls of the aorta become weak and may rupture (break open), causing a major loss of blood with a high risk of serious problems and death. To avoid this risk, doctors repair aneurysms by either open surgery (incision) or endovascular surgery (covered stents to channel the blood flow). Juxtarenal aneurysms (those that come close to the kidney arteries) present a unique challenge as they are more dangerous to repair by open therapy and do not fit the standard approved endovascular devices. The purpose of this study is to assess the effects of the physician-modified endovascular graft (PMEG) by collecting information about the performance of this investigational medical device. The main graft looks like a pair of pants with very short legs. The top of the pants is placed in the aorta. Then, two smaller grafts go from the main graft and to your iliac arteries (the main arteries supplying blood to your abdomen and legs) to form the legs of the pair of pants. Each graft is packed into a small catheter (a long, flexible plastic tube) that is placed into your aorta through the femoral artery in your groin (top of your leg). The grafts are then placed in the correct position in your aorta by releasing them from the catheters. These grafts are invest…
This description comes directly from the study's public registry record.
Erin Daley, MPH, BS · 413-794-8704 · erin.daley2@baystatehealth.org
Hazel Marecki, MD · 413-794-0900 · hazel.marecki@baystatehealth.org
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| Baystate Medical Center | Springfield, Massachusetts, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07019454