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Recruiting
NCT07611968
Prospective Evaluation of Physician Modified Endografts for Aortic Disease
Conditions: Aortic Aneurysm
Sex: All
Ages: 50 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: Mayo Clinic
Location: Mayo Clinic Jacksonville Florida
Summary
The purpose of this research is to assess safety and preliminary effectiveness of the Physician-Modified Terumo Treo Abdominal Stent-Graft System.
Eligibility Criteria
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 \ 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
Source: ClinicalTrials.gov (NCT07611968). StuddyBuddy aggregates publicly available trial information.