Prospective Evaluation of Physician Modified Endografts for Aortic Disease

Prospective Evaluation of Physician Modified Endografts for Aortic Disease

The purpose of this research is to assess safety and preliminary effectiveness of the Physician-Modified Terumo Treo Abdominal Stent-Graft System.

Inclusion Criteria:

• An aneurysm with a maximum diameter of >5.5cm in males and >5.0cm in females in diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements
• Aneurysm with a history of growth > 0.5 cm in 6 months
• Saccular aneurysm deemed at significant risk for rupture
• Symptomatic aneurysm
• Extent of aorta to be treated: type II, III and IV thoracoabdominal.
• Subject is at high-risk of morbidity and mortality with open surgical repair as defined by FEV1 of <1 liter or uncorrectable coronary disease, frailty, hostile abdomen.
• Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit.
• Non-aneurysmal aortic segment proximal to the aneurysm (neck) with a:
• Minimum neck length of 15mm
• Diameter in the range of 17-32
• Minimum branch vessel diameter greater than 5 mm
• Iliac artery distal fixation site
• An inside diameter of 8mm - 13mm and a length of ≥ 10mm or
• an inside diameter of > 13mm - 20mm and a length of ≥ 15mm
• Age: ≥50 years old

Exclusion Criteria:

• Can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis
• Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site
• 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
• Ruptured aneurysms
• Prior aortic repair
• Patient is eligible for treatment with an FDA-approved marketed device and patient can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufacturer-made device at another institution.
• Known sensitivities or allergies to the materials of construction of the devices, including nitinol, polyester, PTFE, stainless steel, platinum/iridium, tantalum markers.
• Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed
• Uncorrectable coagulopathy
• Body habitus that would inhibit x-ray visualization of the aorta or exceed 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 endovascular repair
• 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
• Baseline creatinine greater than 2.0 mg/dL
• Thrombus or excessive calcification within the neck of the aneurysm
• Branch stenosis >50% not amenable to endovascular preparation