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.

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Aneurysm
• Intervention / Treatment: Device: Physician-Modified Terumo Treo Abdominal Stent-Graft System

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pia Geisselmaier; Phone Number: 904-953-2077; Email: Geisselmaier.PiaJulia@mayo.edu

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
      • Contact: Pia Geisselmaier; Phone Number: 904-953-2077; Email: Geisselmaier.PiaJulia@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abdominal aortic aneurysm repair	Device: Physician-Modified Terumo Treo Abdominal Stent-Graft System; A physician modified Terumo Treo abdominal stent-graft system will be used during repair surgery for type II, III and IV thoracoabdominal aortic aneurysms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of study subjects with treatment success at 1 year	Treatment success is defined as freedom from the following: Aneurysm enlargement: >5mm as compared to any previous CT measure using orthogonal (i.e., perpendicular to the centerline) measurements.; Aneurysm rupture; Aneurysm-related mortality; Conversion to open repair; Secondary intervention for migration, Type I and III endoleaks, device integrity failure (e.g., fracture), and patency-related events (i.e., device component stenosis or occlusion and embolic events); Graft infection; Disabling Stroke; Permanent dialysis Results are reported as a percentage	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of procedures that achieve technical success	Technical success is defined as: Successful access to the arterial system using remote arterial exposure, percutaneous technique, or open surgical conduits; Successful delivery and Deployment at the intended implantation site; Successful side branch catheterization and placement of bridging stents with restoration and maintenance of flow in all intended target vessels.; Successful withdrawal of the delivery system; Patency of all endovascular graft and stent components; Absence of device deformations requiring unplanned placement of an additional device; Absence of Type I and III endoleaks at completion angiography that extends beyond 30 days by confirmatory imaging (CTA, MRA or duplex ultrasound) Results are reported as a percentage	1 year

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Young Erben, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): July 15, 2028

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: May 21, 2026
• First Posted (Actual): May 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm
• Other Study ID Numbers: 25-001108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes