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 investigational because the research physician has changed them to match patient anatomy (body make up) while protecting blood flow to important vessels. Once the grafts are attached inside the aorta, they will support the area of the aorta that is weakened and bulging. Modifications of the graft will include between one and four holes (fenestrations) near the top of the graft. The holes allow the graft to be located above the renal arteries (the blood vessels that supply blood to your kidneys) without blocking the blood flow to them. One or more of the arteries will also be treated with a stent (metal wire tube) to help keep the arteries open and to keep the arteries connected to the holes that are made for the graft. The device is custom modified for patient specific anatomy. The information collected from this study will be used to show how well patients do when treated with the modified graft, both immediately after surgery and over a long period of time. After the procedure, labs, CT imaging with contrast, XRays and ultrasounds will be done to check the graft at intervals 1 month, 6 months, 12 months and yearly for 5 years. These are standard surveillance studies performed on any endovascular aneurysm repair.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
This is the only intervention in the study
Baystate Medical Center
Springfield, Massachusetts, United States
RECRUITINGTechnical success
The physician was able to insert the delivery catheter and deliver the physician modified endovascular graft to the treatment site and preserve blood flow into the vessels intended to have blood flow preserved.
Time frame: Periprocedural
Freedom from Type I and III Endoleaks at 12 months
Yes/No Type I or Type III Endoleak visualized on 12 month CT Angiography
Time frame: 12 months post-procedure
Freedom from stent graft migration at 12 months
Yes/No stent migration at 12 months
Time frame: 12 months
Freedom from aortic aneurysm enlargement at 12 months
Yes/No Freedom from enlargement maximal aortic diameter
Time frame: 12 months
Freedom from aortic aneurysm rupture and conversion to open repair through 12 months
Yes/No freedom from
Time frame: 12 months
Mortality
Yes/No
Time frame: 30 days, 6 months, 12 months, and annually through 5 years
Aneurysm related mortality
Yes/ No
Time frame: 30 days, 6 months, 12 months, and annually through 5 years
Aneurysm Rupture
Yes/ No
Time frame: 30 days, 6 months, 12 months, and annually through 5 years
Major Adverse Events
Time frame: 30 days, 6 months, 12 months, and annually through 5 years
Renal failure with or without permanent dialysis
Yes/No, with or without dialysis
Time frame: 30 days, 6 months, 12 months, and annually through 5 years
Graft Infection
Yes/ No
Time frame: 30 days, 6 months, 12 months, and annually through 5 years
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