Using modified endovascular grafts to treat complex aortic aneurysms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hartford Hospital
  Hartford, Connecticut, United States Recruiting

Study contacts

• Study coordinator: Akhilesh K Jain, MD
• Email: akhilesh.jain@hhchealth.org
• Phone: 860-522-4158

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Physician-modified endografts for aortic disease in high-risk patients

  This study tests a physician-modified Terumo Treo abdominal stent-graft to see if it can safely treat large aortic aneurysms in patients who are high-risk for open surgery.

  Recruiting Mayo Clinic · Jacksonville, Florida · NCT07611968

• Using AI to measure aortic size from CT scans

  This project will test whether an AI tool called Aorta AIM can automatically measure the aorta on CT scans for adults who have or are being checked for aortic aneurysms.

  Recruiting Aiatella Oy · Chapel Hill, North Carolina and 2 other locations · NCT07438327

• Measuring the shape and strength of the ascending aorta in patients having heart surgery

  We will test whether direct measurements of the aortic wall's mechanical properties taken during heart surgery can better characterize rupture or dissection risk in people with ascending aortic aneurysm by comparing them to patients undergoing heart transplantation without known aortic disease.

  Recruiting Fondazione IRCCS Policlinico San Matteo di Pavia · Pavia, Lombardy · NCT07422129

• BAO-G technique for repairing complex thoracoabdominal and abdominal aortic aneurysms

  This study will try the BAO-G endovascular technique, which uses off-the-shelf iliac branched devices to rebuild visceral branches in patients with complex thoracoabdominal or abdominal aortic aneurysms who are candidates for endovascular repair.

  Recruiting at 11 sites Peking Union Medical College Hospital · Beijing, Beijing Municipality and 10 other locations · NCT07141251

• Rapidlink device for repairing aortic arch branch vessels during open thoracic aorta surgery

  This study will test whether the Rapidlink device can help surgeons repair or replace the arteries branching from the aortic arch during open surgery for thoracic aortic disease.

  Recruiting at 7 sites Vascutek Ltd. · Los Angeles, California and 20 other locations · NCT07078383

• Understanding exercise effects on aortic aneurysm patients

  This study is testing how exercise affects people with aortic aneurysms to help find safe activity levels that could improve their health.

  Recruiting The Cleveland Clinic · Cleveland, Ohio · NCT06789809

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.