Fenestrated TREO stent-graft repair for juxtarenal abdominal aortic aneurysm

A Prospective, Multicenter, Non-Blinded, Non-Randomized Pivotal Study of the Fenestrated TREO Stent-Graft System in Subjects With Abdominal Aortic Aneurysms Requiring a Fenestrated Graft and Suitable for Endovascular Repair

This trial will test whether a fenestrated TREO stent-graft can safely repair juxtarenal abdominal aortic aneurysms in adults who are candidates for endovascular treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Bolton Medical (Industry-sponsored)
• Locations: 7 sites (Colorado Springs, Colorado and 6 other locations)
• Trial ID: NCT07026877 on ClinicalTrials.gov

What this trial studies

Adults with juxtarenal abdominal aortic aneurysms that meet specific CT-based anatomical criteria will receive a fenestrated TREO stent-graft placed through an endovascular procedure. Participants will have regular follow-up visits, imaging, and safety checks over a five-year period to monitor device performance and complications. The protocol targets aneurysms that require preservation of one or more renal arteries with fenestrations tailored to the patient anatomy. Outcomes will include procedural success, device-related adverse events, and aneurysm-related imaging results over time.

Who should consider this trial

Good fit: Ideal candidates are adults with juxtarenal or aorto-iliac aneurysms that meet the CT-based size and anatomical criteria for a fenestrated endovascular repair and who have a life expectancy greater than two years.

Not a fit: Patients with aneurysm anatomy unsuitable for a fenestrated endovascular approach, significant comorbidities limiting life expectancy, or other contraindications to endovascular repair are unlikely to benefit from this device.

Why it matters

Potential benefit: If successful, the device could offer a less invasive option to repair juxtarenal AAAs while preserving renal artery blood flow.

How similar studies have performed: Fenestrated endovascular aneurysm repair (FEVAR) approaches have shown success in prior studies, though the TREO fenestrated system itself is being specifically tested in this protocol.

Eligibility criteria

Inclusion Criteria:

* 18 years or older at the time of consent
* Life expectancy is greater than 2 years
* An abdominal aortic or aorto-iliac aneurysm requiring a fenestrated graft and with morphology suitable for endovascular repair (confirmed by Computed Tomography (CT) with contrast performed within 6 months of planned implant procedure) as follows:

  1. Maximum aneurysm diameter of ≥5.5 cm for male ( ≥5.0 cm for female) or
  2. Maximum AAA diameter exceeding two times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements (or saccular aneurysm that warrants treatment in the opinion of the investigator) or
  3. Aneurysm with a history of growth \> 0.5 cm in 6 months and
  4. Minimum 0 mm of healthy aorta\* below the most inferior renal artery that the physician plans on preserving and no renal artery involvement (juxtarenal aneurysms) or
  5. At least one renal artery involved in the aneurysm and minimum 2 mm below the celiac (suprarenal aneurysms) \*Healthy aorta is defined as segment of aorta with parallel aortic wall with minimal (\<10%) or no difference in diameter and minimal atherosclerotic debris, thrombus, or calcification.
* Proximal landing zone:

  1. ≥20 mm length
  2. 20-32 mm diameter
  3. ≤60° angle relative to the axis of the suprarenal aorta
  4. ≤60° angle relative to the long axis of the aneurysm
* Distal (iliac) landing zone with:

  1. 8-13 mm inside diameter/ ≥10 mm length
  2. \>13-20 mm inside diameter/ ≥15 mm length
* Distal aortic diameter (above the iliac bifurcation) ≥70% of the sum of the iliac limb graft diameters
* Minimum 18 mm aortic lumen diameter at the level of the fenestrations
* Pathology that requires maximum 5 fenestrations in the main body
* Pathology that requires fenestration a minimum 3 mm apart (edge to edge)
* Branch vessels (to be bridged to the fenestrated graft) with:

  1. 5-9 mm diameters
  2. ≥13 mm distal landing zone (or ≥15 mm if there is a gap between fenestration and target vessel)
* Adequate renal function to tolerate contrast-enhanced CTA
* Adequate vascular access compatible with required delivery systems
* Willingness to comply with the follow-up evaluation schedule documented in a signed informed consent prior to implant

Exclusion Criteria:

* Pregnant or lactating
* Existing endovascular graft in the treated segment intended to be repaired with the Fenestrated TREO Stent-Graft System
* Dissection in abdominal aorta, ruptured aneurysm, or symptomatic aneurysm (as determined by treating physician)
* Implant procedure as planned does not allow for at least one patent hypogastric artery left intact, unless both are occluded on pre-op imaging.
* A branch vessel(s) that is dissected or has significant calcification, tortuosity, thrombus formation that would interfere with bridging stent delivery or sealing (as determined by treating physician)
* Severe untreated coronary artery disease and/or unstable angina, significant areas of myocardium at risk (based on coronary angiogram or radionuclide scans), left ventricular ejection fraction \<20%, or recent diagnosis of congestive heart failure (CHF; as determined by treating physician).
* Stroke or myocardial infarction within 6 months of the planned treatment date
* Chronic obstructive pulmonary disease requiring routine need for oxygen therapy outside the hospital setting (e.g., daily or nightly home use)
* Chronic Kidney Disease (CKD) stage ≥3b.\*

  \* During Stage 2, patients with severe CKD (stage ≥3b) can be included in the Expanded Access Arm if otherwise eligible.
* Active systemic infection or is suspected of having an active systemic infection (e.g., acquired immune deficiency syndrome (AIDS)/human immunodeficiency virus (HIV), sepsis)
* Clinical conditions that would severely compromise or impair x-ray visualization of the aorta (as determined by treating physician).
* History of an aortopathic connective tissue disease (e.g., Marfan's syndrome)
* Mycotic aneurysm
* Significant or circumferential calcification or mural thrombus (as determined by treating physician):

  1. in the proximal aortic neck
  2. in the distal iliac landing zone
  3. within the treatment length, which may adversely impact device patency
* Cannot receive intraprocedural anticoagulation per the investigator's standard of care, or antiplatelet therapy post-procedurally as per the investigator's standard of care.
* Blood coagulation disorder or bleeding diathesis, the treatment for which cannot be suspended pre- and post-repair
* An investigational study drug or biologic within 30 days of planned procedure or an investigational device within one year of planned procedure or any other treatment that may interfere with the interpretation of the study results.
* Medical, social or psychological issues that the investigator believes may interfere with study treatment or follow-up.
* Untreatable allergy or sensitivity to contrast media, nitinol/nickel, Tantalum, Platinum Iridium (PtIr), 316 stainless steel, ePTFE (expanded polytetrafluoroethylene), PTFE (polytetrafluoroethylene) Impregnated polyester fiber, or polyester
* Other major surgical or medical intervention within 45 days of the planned procedure or plan to undergo other major surgical or medical intervention within 45 days post implantation (e.g., coronary artery bypass graft (CABG), organ transplantation, renal stenting)

Where this trial is running

Colorado Springs, Colorado and 6 other locations

• UC Health Memorial — Colorado Springs, Colorado, United States (Recruiting)
• Tampa General Hospital — Tampa, Florida, United States (Not_yet_recruiting)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
• Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
• Mt. Sinai — New York, New York, United States (Active_not_recruiting)
• Baylor Scott and White Research Institute — Plano, Texas, United States (Active_not_recruiting)
• University of Washington Medical Center — Seattle, Washington, United States (Recruiting)

Study contacts

• Principal investigator: Benjamin W Starnes, MD — University of Washington
• Study coordinator: Lauren Rider

Conditions Abdominal Aortic Aneurysms; Abdominal Aortic Aneurysm; juxtarenal; endovascular