RECRUITING

Laser In Situ Fenestration Study

Conditions

Aortic Aneurysm Endovascular Aneurysm Repair Fenestrated Endovascular Aneurysm Repair

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to learn about a new device, named the LIFE device, to treat people with aneurysms (swellings) in the aorta (large, main blood vessel that delivers blood from the heart to the body). The main questions this trial aims to answer are: * If the LIFE device works to treat aortic aneurysms * What medical problems participants have when the LIFE device is used Participants will undergo treatment with the LIFE device and thereafter at 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years have their pulses checked, bloodwork to check kidney function (BUN and serum creatinine), and a CT scan of the aneurysm area.

Official Title

Laser In Situ Fenestration for Endovascular Aortic Repair (LIFE) Study

Quick Facts

Study Start:2024-10-15

Study Completion:2031-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06411990

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Jennifer Randolph, Nurse, Clinical Research, RN, BSN

CONTACT

573-882-4387

randolphjl@health.missouri.edu

Principal Investigator

Jonathan Bath, MD

PRINCIPAL_INVESTIGATOR

University of Missouri School - Columbia

Study Locations (Sites)

University of Missouri - Columbia

Columbia, Missouri, 65212

United States

Collaborators and Investigators

Sponsor: Jonathan Bath

Jonathan Bath, MD, PRINCIPAL_INVESTIGATOR, University of Missouri School - Columbia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-15

Study Completion Date2031-06

Study Record Updates

Study Start Date2024-10-15

Study Completion Date2031-06

Terms related to this study

Keywords Provided by Researchers

Fenestrated Endovascular Aneurysm Repair

Additional Relevant MeSH Terms

Aortic Aneurysm
Endovascular Aneurysm Repair