Using a new device to treat 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 trial evaluates the effectiveness of the LIFE device in treating aortic aneurysms located near the kidney arteries. Participants will receive treatment with the LIFE device, which is designed to cover tears or leaks in the aorta while allowing blood flow to vital branches. The study will monitor participants over a period of five years, assessing their health through pulse checks, blood tests, and CT scans to evaluate the aneurysm. The trial specifically targets patients who are not candidates for traditional endovascular or open repair methods.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aortic aneurysm \>5.5 cm in a man or \> 5.0 cm in a woman or rapid expansion deemed at significant risk for rupture in the juxtarenal or pararenal aorta.
2. Endovascular aortic repair requiring coverage of renovisceral branches.
3. Not candidate or at high risk for open repair. For example, but not exclusively, due to renal dysfunction, previous abdominal surgery, obese body habitus, previous coronary bypass grafts or high cardiac risk, chronic obstructive pulmonary disease (COPD) or on oxygen at rest, poorly controlled diabetes, current smoking, or antiplatelet or anticoagulation use.
4. Proximal aortic landing zone in Zone 5 of the aorta or previous graft of at least 10 mm in length and diameter of between 20 and 40 mm.
5. Distance ≥ 5 mm between top of graft fabric and renovisceral branch orifice.
6. At least a 5 mm iliofemoral artery to accept the endovascular stent graft device and an axillary brachial artery of sufficient diameter to accept the laser catheter.
7. Renovisceral diameter between 4 and 13 mm at the origin.
8. At the time of case planning, the patient's anatomy appears amenable to complete exclusion of the aneurysm with laser fenestration techniques.
9. Not willing or able to travel to sites that have access to manufacturer-made investigational endovascular devices.
10. Not a candidate for currently approved endovascular options.
11. 18 years or older.
12. Patient or legally authorized representative agrees to participate in the study and provides written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization.
13. Patient is able and willing to meet all study requirements, including participating in follow up evaluations and attending required assessment visits.

Exclusion Criteria:

1. Known sensitivities or allergies to the materials of construction of the devices, including Nitinol, polyester, Platinum-Iridium, stainless steel, fluoropolymer, and heparin.
2. Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed.
3. Uncorrectable coagulopathy.
4. Body habitus that would inhibit radiographic visualization of the aorta or exceeds the safe capacity of equipment.
5. Concurrent participation in another research protocol for investigation of an experimental therapy.
6. Subject has been judged to be unsuitable for participation in the study by the Investigator for any reason.

Where it's running

• University of Missouri - Columbia
  Columbia, Missouri, United States Recruiting

Study contacts

• Principal investigator: Jonathan Bath, MD — University of Missouri School - Columbia
• Study coordinator: Jennifer Randolph, Nurse, Clinical Research, RN, BSN
• Email: randolphjl@health.missouri.edu
• Phone: 573-882-4387

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.

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• 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

• 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

• Using modified endovascular grafts to treat 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.

  Recruiting Hartford Hospital · Hartford, Connecticut · NCT06834607

• 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.