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

Launched by AKHILESH JAIN · Feb 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a special type of treatment called Physician-Modified Endovascular Grafts for people with complex aortic aneurysms, specifically those that are located near the kidneys. An aortic aneurysm is a bulge in the aorta, the large blood vessel that carries blood from the heart to the rest of the body. This trial is looking for patients who are at high risk for traditional surgery and may have limited options for safe treatment. To be eligible, participants must be at least 18 years old and have a specific type of aneurysm that meets certain size or growth criteria, among other health requirements.

If you or a loved one qualifies for this trial, you can expect to undergo a procedure using these specially designed grafts to repair the aneurysm. Participants will also need to agree to regular follow-up visits to monitor their health after the procedure. It's important to note that this trial is not yet recruiting participants, so there will be more information available later for those interested in taking part.

Gender

ALL

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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