Actively Recruiting
Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms
Led by The Cleveland Clinic · Updated on 2025-06-24
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Physician-Modified Endovascular Grafts to repair juxtarenal aortic aneurysms in high-risk patients who are not suitable candidates for open surgical repair. This study focuses on subjects with limited or no other treatment options and appropriate anatomy. The goal is to assess the safety and preliminary effectiveness of these modified grafts for treating elective, symptomatic, or ruptured juxtarenal aneurysms. The intervention involves implanting a Physician-Modified Terumo Aortic TREO abdominal stent graft system. This device is an off-the-shelf endograft altered during the procedure by adding fenestrations to preserve blood flow to vital branch vessels, which are supported by covered balloon expandable stents. The study tracks treatment success immediately, at 30 days, and then at 6 months, 12 months, and annually up to 5 years. Participants will undergo follow-up assessments including evaluations of major adverse events, technical success, device integrity, and aneurysm changes over time. Researchers will monitor outcomes such as stent graft migration, endoleaks, and the need for additional interventions. The total participation may last up to five years, with visits and safety checks scheduled to ensure thorough monitoring of the device's performance and patient health.
CONDITIONS
Brief Title
Physician Modified Endovascular Grafts for the Treatment of Juxtarenal Aortic Aneurysms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years of age or older
- Male or non-pregnant female (females of childbearing potential must have a negative pregnancy test before enrollment)
- Patient or legally authorized representative has signed an IRB-approved informed consent form
- Patient has a juxtarenal abdominal aortic aneurysm meeting at least one of the following: diameter ≥ 5.5 cm for males or ≥ 5.0 cm for females, aneurysm growth > 0.5 cm in 6 months, saccular aneurysm at significant risk of rupture, symptomatic aneurysm, or ruptured aneurysm
- Patient has patent iliac or femoral arteries allowing endovascular access
- Patient has a suitable non-aneurysmal proximal aortic neck ≥ 2 mm below the lowest renal artery
- Patient has a suitable non-aneurysmal distal iliac artery length of ≥ 15 mm preserving at least one hypogastric artery
- Proximal aortic neck diameter between 20 and 32 mm
- Distal common iliac diameters between 8 and 20 mm
- Juxtarenal aortic neck angulation ≤ 60°
- Target branch vessel diameter ≥ 5 mm
- Patient is willing to comply with all required follow-up exams
You will not qualify if you...
- Patient has a mycotic aneurysm or active systemic or local infection
- Patient has unstable angina
- Patient has a major surgical or interventional procedure planned within 30 days before or after the aneurysm repair
- History of aortopathic connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome)
- Known hypersensitivity or contraindication to anticoagulation or contrast media not manageable by pre-treatment
- Known allergy or intolerance to stainless steel, nitinol, or gold
- Body habitus that prevents X-ray visualization of the aorta
- Limited life expectancy of less than 1 year
- Currently participating in another investigational device or drug clinical trial
- Medical, social, or psychological conditions that preclude treatment and evaluations
- Thrombus or excessive calcification within the aneurysm neck
- Branch vessel stenosis ≥ 80%
- Suitable for FDA-approved EVAR or FEVAR device and can wait for device availability
- Eligible and willing to enroll in a manufacturer-sponsored study at the site or another institution
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single procedure with acute assessment
Participants undergo implantation of a Physician-Modified Terumo Aortic TREO abdominal stent graft system to repair juxtarenal aortic aneurysms.
1 procedure visit (in-person) and follow-up visits
Duration - Up to 5 years
Participants are monitored for safety and effectiveness of the device through scheduled visits over several years.
Visits at 30 days, 6 months, 12 months, and annually up to 5 years
Trial Site Locations
Total: 1 location
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
Y
Yuki Kuramochi, BSN, RN
J
Jeannine Ramsey, BSN, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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