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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07611968). StuddyBuddy aggregates publicly available trial information.