Using modified endovascular grafts to treat complex aortic aneurysms

Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Complex Aortic Aneurysms

This study is testing if specially modified grafts can safely repair complex aortic aneurysms in high-risk patients who can’t have regular surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hartford Hospital (Academic / other)
• Locations: 1 site (Hartford, Connecticut)
• Trial ID: NCT06834607 on ClinicalTrials.gov

What this trial studies

This clinical investigation evaluates the safety and effectiveness of physician-modified endovascular grafts for repairing juxtarenal aortic aneurysms in high-risk patients who are not suitable for traditional surgical options. The study will assess treatment success and major adverse events at various time points, including 30 days, 6 months, 12 months, and annually for up to 5 years. Participants must have specific anatomical criteria and meet certain health conditions to qualify for the intervention.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with juxtarenal abdominal aortic aneurysms that meet specific size or symptomatic criteria.

Not a fit: Patients with aortic aneurysms that do not meet the inclusion criteria or those who are not considered high-risk for open surgical repair may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a less invasive treatment option for patients with complex aortic aneurysms, potentially reducing the risk of complications associated with open surgery.

How similar studies have performed: While the use of modified endovascular grafts is a novel approach, similar studies have shown promise in treating complex aortic conditions, indicating potential for success.

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.

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Where this trial is running

Hartford, Connecticut

• Hartford Hospital — Hartford, Connecticut, United States (Recruiting)

Study contacts

• Study coordinator: Akhilesh K Jain, MD

Conditions Juxta Renal Abdominal Aortic Aneurysm Without Rupture; Complex Aortic Aneurysms; Aortic Aneurysm; Physician Modified Endograft; PMEG; Complex aortic aneurysms; Juxta renal aortic aneurysm