Physician-modified endovascular grafts to treat juxtarenal abdominal aortic aneurysms

Baystate Health Physician Sponsored - Investigational Device Exception: Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms

This study tries a physician-modified stent graft to repair juxtarenal abdominal aortic aneurysms in adults with elective, symptomatic, or ruptured aneurysms.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Baystate Medical Center (Academic / other)
• Locations: 1 site (Springfield, Massachusetts)
• Trial ID: NCT07019454 on ClinicalTrials.gov

What this trial studies

This single-center interventional protocol uses physician-modified endovascular grafts (PMEGs) to treat juxtarenal abdominal aortic aneurysms that are not suitable for standard off-the-shelf devices. Eligible adults undergo endovascular placement of a modified covered stent graft with physician-created openings or adjustments to preserve renal and visceral blood flow. Key outcomes tracked at 12 months include technical success, freedom from type I and III endoleaks, stent graft migration, aneurysm enlargement, and aneurysm rupture or conversion to open repair. Data will be collected to characterize device performance and short-term durability in elective, symptomatic, and ruptured cases.

Who should consider this trial

Good fit: Adults (≥18 years) with juxtarenal abdominal aortic aneurysms meeting size, growth, symptomatic, or rupture criteria and with adequate iliac/femoral access for endovascular delivery are the intended candidates.

Not a fit: Patients whose aneurysms are not juxtarenal, who lack adequate vascular access, or who are poor candidates for endovascular repair are unlikely to benefit from this procedure.

Why it matters

Potential benefit: If successful, this approach could offer a less invasive repair option that preserves kidney blood flow and reduces the need for open surgery in patients with juxtarenal aneurysms.

How similar studies have performed: Physician-modified and fenestrated endograft approaches have shown promising results in observational series at specialized centers, but large randomized data are limited.

Eligibility criteria

Inclusion Criteria:

1. Patient is ≥ 18 years of age
2. Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study)
3. Patient or Legally Authorized Representative has signed an Institutional Review Board (IRB) approved Informed Consent Form
4. Patient has a juxtarenal abdominal aortic aneurysm that meets at least one of the following:

   1. An aneurysm with a maximum diameter of ≥ 5.5 cm for male (≥ 5.0 cm for female) or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements
   2. Aneurysm with a history of growth \> 0.5 cm in 6 months
   3. Saccular aneurysm deemed at significant risk for rupture
   4. Symptomatic aneurysm
   5. Ruptured aneurysm
5. Patient has patent iliac or femoral arteries, with or without the use of conduit, that will allow endovascular access with the physician modified endovascular graft.
6. Patient has a suitable non-aneurysmal proximal aortic neck of ≥ 2 mm inferior to the most distal renal artery ostium.
7. Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥ 15mm. The resultant repair should preserve patency in at least one hypogastric artery.
8. Patient has a suitable non-aneurysmal proximal aortic neck diameter between 20 and 32 mm, averaged across the diameters at the Celiac, SMA, at the lowest patent renal artery and at the midpoint of the renal arteries.
9. Patient has suitable non-aneurysmal distal common iliac diameters between 8 and 20 mm.
10. Patient has juxtarenal aortic neck angulation ≤ 60°
11. Target branch vessel diameter ≥ 5 mm.
12. Patient must be willing to comply with all required follow-up exams.

Exclusion Criteria:

1. Patient has a mycotic aneurysm or has an active systemic or local infection that may increase the risk of endovascular infection
2. Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)
3. Patient has a major surgical or interventional procedure, not related to the endovascular repair, planned within +/- 30 days of the AAA repair.
4. Patient has history of an aortopathic connective tissue disease (e.g. Marfan's or Ehler's- Danlos syndrome).
5. Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.
6. Patient has known allergy or intolerance to stainless steel, nitiol, or gold (gold-plated tungsten)
7. Patient has a body habitus that would inhibit X-ray visualization of the aorta
8. Patient has a limited life expectancy of less than 1 year
9. Patient is currently participating in another investigational device or drug clinical trial
10. Patient has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post- treatment procedures and evaluations.
11. Thrombus or excessive calcification within the neck of the aneurysm
12. Branch vessel stenosis ≥ 80 %
13. Patients treatable on label with FDA approved EVAR or FEVAR device and can wait for device availability.
14. Subject is willing and eligible to enroll in a manufacturer-sponsored study at the investigational site, or the subject is willing and eligible to participate in a study with a manufacturer-made device at another institution.

Where this trial is running

Springfield, Massachusetts

• Baystate Medical Center — Springfield, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Hazel Marecki, MD — Baystate Medical Center
• Study coordinator: Erin Daley, MPH, BS

Conditions Technical Sucess; Freedom From Type I and III Endoleaks at 12 Months; Freedom From Stent Graft Migration at 12 Months; Freedom From Aortic Aneurysm Enlargement at 12 Months; Freedom From Aortic Aneurysm Rupture or Conversion to Open Repair at 12 Months; complex endovascular aortic aneurysm repair; PMEG; juxtarenal