Physician-modified endografts for aortic disease in high-risk patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, interventional study evaluates the safety and preliminary effectiveness of using physician-modified Terumo Treo abdominal stent-grafts to treat aneurysms of the thoracoabdominal aorta in patients at high risk for open repair. Eligible participants have large aneurysms, evidence of growth, or rupture risk, and suitable vascular anatomy for endovascular access. The procedure uses a customized graft approach performed by experienced physicians at Mayo Clinic, focusing on suitability, technical feasibility, and early outcomes. Outcomes of interest include perioperative safety, device performance, and short-term aneurysm repair durability. This study aims to inform whether this modification-based strategy can offer a less invasive option for high-risk patients.

Why it matters

Who can join: the full rules

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

Where it's running

• Mayo Clinic
  Jacksonville, Florida, United States Recruiting

Study contacts

• Principal investigator: Young Erben, MD — Mayo Clinic
• Study coordinator: Pia Geisselmaier
• Email: Geisselmaier.PiaJulia@mayo.edu
• Phone: 904-953-2077

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.