Prospective Evaluation of Physician Modified Endografts for Aortic Disease

A vizsgálat adatai

Ki végzi

Mayo Clinic

Azonosító

NCT07611968

A regiszteradat frissítve

2026. július 13.

Eredeti leírás

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

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

Bevonási feltételek: 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.

Kizáró feltételek: 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; Subject has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned < 30 days of endovascular repair; 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; 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; 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; Uncorrectable coagulopathy; Body habitus that would inhibit x-ray visualization of the aorta or exceed the safe capacity of the equipment; Thrombus or excessive calcification within the neck of the aneurysm; Branch stenosis >50% not amenable to endovascular preparation.

ClinicalTrials.gov NCT07611968