Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified Endovascular Grafts (PMEGs)

INCLUSION CRITERIA:

General inclusion criteria (applicable to all 3 study arms):

• Aortic pathology that fits one of the study arms (see below for detaileddescription)

• Aortic pathology that cannot be treated within the Instructions for Use of an FDA-approved, commercially-available device

• Aortic aneurysm that can be treated within the Instructions for Use of anFDA-approved, commercially-available custom-manufactured device but deemed unsafe towait the required time for device manufacturing

• Subject is at high-risk of morbidity and mortality with open surgical repair basedon cardiopulmonary function, extent of comorbid disease, and anatomic complexity

• Iliac and/or femoral access vessel morphology that is compatible with vascularaccess techniques, devices, or accessories, with or without use of a surgical orendovascular conduit

• Non-aneurysmal aortic segment proximal to the aortic pathology with a:

• Minimum neck length of 20 mm

• Diameter between 20 - 42 mm

• Non-aneurysmal aortic or iliac segment distal to the aortic pathology with:

• Aortic distal fixation site greater than 20 mm in length and diameter between 20-42 mm

• Iliac artery distal fixation site greater than 10 mm in length and diameterrange 8- 25 mm

• Age ≥21 years old

• Life expectancy: ≥2 years

Arm1:

• Complex abdominal aortic aneurysm, specifically juxtarenal or suprarenal abdominalaortic aneurysm or type IV thoracoabdominal aortic aneurysm, with maximum diameterof ≥5.5 cm for men or ≥5.0 cm for women, growth ≥0.5 cm in 6 months, or concomitantiliac aneurysm ≥3 cm

• Prior endovascular aortic aneurysm repair with loss of proximal seal requiringincorporation of the renal arteries, SMA, and/or CA for repair, without aneurysmaldisease extending above the diaphragmatic hiatus

• Prior open abdominal aortic aneurysm repair with aneurysmal disease proximal to therepair requiring incorporation of the renal arteries, SMA, and/or CA for repair,without aneurysmal disease above the diaphragmatic hiatus

• Saccular complex abdominal aortic aneurysm deemed at significant risk for rupture

• Symptomatic complex aortic aneurysm

• Penetrating aortic ulcer with depth ≥1 cm or width ≥2 cm, for which endovascularrepair requires incorporation of the renal arteries, SMA, and/or CA, withoutinvolvement of the aorta above the diaphragmatic hiatus

• Aortic pseudoaneurysm for which endovascular repair requires incorporation of therenal arteries, SMA, and/or CA, without involvement of the aorta above thediaphragmatic hiatus

Arm2:

• Type I, II, or III thoracoabdominal aortic aneurysm with maximum diameter of ≥5.5cm, or growth ≥0.5 cm in 6 months

• Prior endovascular aortic aneurysm repair with loss of proximal seal requiringincorporation of the renal arteries, SMA, and/or CA for repair with aneurysmaldisease extending above the diaphragmatic hiatus

• Prior thoracic endovascular aneurysm repair with loss of distal seal requiringincorporation of the renal arteries, SMA, and/or CA for repair

• Prior open abdominal aortic aneurysm repair with aneurysmal disease proximal to therepair requiring incorporation of the renal arteries, SMA, and/or CA for repair,with aneurysmal disease above the diaphragmatic hiatus

• Saccular type I, II, or III thoracoabdominal aortic aneurysm deemed at significantrisk for rupture

• Symptomatic type I, II, or III thoracoabdominal aortic aneurysm

• Penetrating aortic ulcer with depth ≥1 cm or width ≥2 cm, for which endovascularrepair requires incorporation of the renal arteries, SMA, and/or CA, withinvolvement of the aorta above the diaphragmatic hiatus

• Aortic pseudoaneurysm for which endovascular repair requires incorporation of therenal arteries, SMA, and/or CA, with involvement of the aorta above thediaphragmatic hiatus

Arm 3:

• Acute or chronic type B aortic dissection with indication for repair including, butnot limited to renal, mesenteric, or lower extremity malperfusion, progression ofdissection, or persistence of symptoms despite optimal medical therapy

• Prior repair of type A dissection and development of acute or chronic type Bdissection component with indication for repair (listed above)

• Aortic intramural hematoma (IMH) with indication for repair including, but notlimited to renal, mesenteric, or lower extremity malperfusion, progression ofdissection, or more typically, persistence of symptoms despite optimal medicaltherapy

Arm 4

• Patient does not meet the inclusion/exclusion criteria of Arms 1 - 3

• Patient has prohibitive operative risk for open repair and no other viableendovascular treatment option

• Estimated perioperative risk is lower than the estimated 1-year mortality withoutsurgery

EXCLUSION CRITERIA:

General Exclusion Criteria

• Subject is eligible for enrollment in a manufacturer-sponsored IDE at theinvestigational site

• Subject is unwilling to comply with the follow-up schedule

• Inability or refusal to give informed consent by subject or legal representative

• Subject is pregnant or breastfeeding

• Subject has a ruptured aneurysm

Medical Exclusion Criteria

• Known sensitivities or allergies to the materials of construction of the devices

• Known hypersensitivity or contraindication to anticoagulation or contrast media thatcannot be adequately medically managed

• Uncorrectable coagulopathy

• Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safecapacity of the equipment

• Systemic or local infection that may increase the risk of endovascular graftinfection

• Diagnosis of connective tissue disorders (e.g., Marfan Syndrome, Ehler's DanlosSyndrome)

Anatomic Exclusion Criteria

• Inability to perform open or endovascular iliac conduit in patients with inadequatefemoral/iliac access

• Excessive thrombus or calcification within the neck of the aneurysm

• Visceral vessel anatomy not compatible with placement of a physician-modifiedendovascular graft due to occlusive disease or small size