Custom stent grafts offer new hope for High-Risk aneurysm patients

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient is \> 18 years of age. * Patients who are male or non-pregnant female (females of childbearing potential must have a negative pregnancy test prior to enrollment into the study) * Patient is able and willing to sign an Institutional Review Board (IRB) approved Informed Consent Form * The subject has at least one of the following: 1. . An aortic or aortoiliac aneurysm with a maximum diameter of ≥ 5.5cm for males, ≥ 5.0cm for females 2. Aortic Aneurysm with a history of growth ≥ 0.5 cm in 6 mos. 3. Symptomatic aneurysm 4. Morphology such as saccular aneurysms 5. Aneurysms meeting any of the above criteria a-e above or below the previous endovascular and/or open aortic repairs. Previously placed aortic stent graft or open aortic grafts may serve as seal zones. * Cannot be treated with a currently available non-modified approved device. * Patient has patent iliac or femoral arteries that will allow endovascular access with the physician modified graft or is suitable for an iliac conduit. * Patient has a suitable non-aneurysmal proximal aortic neck length (seal zone) of ≥ 20mm. * Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥15mm. * The resultant repair should preserve patency in at least one hypogastric artery. * Patient has suitable non-aneurysmal distal common iliac diameters between 7 and 20mm. * Chronic Dissection with aneurysmal degeneration that meets size criteria as described above for repair * Type 1A endoleak requiring extension above the previous repair into the pararenal or paravisceral portion of the aorta to achieve 2 cm of seal. Exclusion Criteria: * patient has a mycotic aneurysm * patient has a systemic or local infection that may increase the risk of graft infection. * Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment. * Subject has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned \< 30 days of the endovascular repair. * Patient is currently participating in another investigational device or drug clinical trial. * Eligible for treatment with FDA-approved marketed device * Can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufacturermade device at another institution. * Unwilling to comply with the follow-up schedule. * Inability or refusal to give informed consent by subject or legal representative. - The subject is pregnant or breastfeeding. * Known sensitivities or allergies to the materials of construction of the devices, including stainless steel, polyester, polypropylene, nickel, titanium, or gold. - Known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pretreatment * Uncorrectable coagulopathy * Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina) * Systemic or local infection that may increase the risk of endovascular graft infection. * History of connective tissue disorders (e.g., Marfan Syndrome, Ehlers's Danlos Syndrome) without landing zone created from graft via previous open repair. - Patient has active malignancy with life expectancy of less than 2 years. * Patient has a limited life expectancy of less than 2 years. * Patient has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pretreatment, required treatment, and post-treatment procedures and evaluations. * Anatomical exclusion criteria such as significant occlusive disease, tortuosity or calcification that would prevent endovascular access. * proximal seal site with a circumferential thrombus/atheroma * inability to maintain at least one hypogastric artery. * shaggy aorta * patient is not amenable to a temporary or permanent open surgical or endovascular conduit. * Thrombus or excessive calcification within the neck of the aneurysm