Aortic Aneurysm, Endovascular Aneurysm Repair
Conditions
Keywords
Fenestrated Endovascular Aneurysm Repair
Brief summary
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.
Detailed description
In this clinical trial the LIFE device is used to treat people with aneurysms in the aorta near the kidney arteries (called juxtarenal or pararenal aortic aneurysms). Tubes, called stent grafts, are typically inserted through blood vessels in the groin and placed inside the aorta in the abdomen and chest area (endovascularly placed) to cover the tear or leak in the aorta. The LIFE device covers the tear or leak and has side branches to let blood flow into the kidney, spleen, intestine, or liver arteries. Participants in this study are not candidates for endovascular devices approved for endovascular aorta repair to the juxtarenal or pararenal aorta, not candidates for open repair, not willing to travel to sites that have access to manufacturer-made endovascular devices, and patients for whom there are no favorable alternatives, for example, urgent, symptomatic, and emergency cases.
Interventions
DEVICEFenestrated Endovascular Aneurysm Repair using the LIFE Device System
Fenestrated Endovascular Aneurysm Repair
Sponsors
Jonathan Bath
University of Missouri-Columbia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, single arm clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with freedom from death and major adverse events (MAE) | 30 days | Number of subjects with freedom from all cause mortality and freedom from major adverse events. Major adverse events include myocardial infarction, chronic renal insufficiency / chronic renal failure requiring, dialysis, bowel ischemia, stroke, paraplegia or paraparesis, and prolonged ventilatory support. |
| Number of participants with device procedure technical success and freedom from endoleak, migration, aortic enlargement, aortic rupture, and aortic or branch-related reinterventions in | 12 months | Device technical success (at the end of index procedure) and freedom from Type I and III endoleak, device migration ≥ 10 mm, aortic enlargement ≥ 5 mm, aortic rupture, and aortic or branch-related reinterventions, including conversion to open repair (within 12 months of the index procedure) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with delivery and deployment of the LIFE Device System | Procedure | Ability to deliver and deploy the LIFE Device System |
| Number of participants with delivery and deployment of the thoracic/abdominal stent graft | Procedure | Ability to deliver and deploy the thoracic/abdominal stent graft |
| Number of participants with coverage of intended aneurysm | Procedure | Ability to cover the intended aneurysm |
| Number of participants with contrast flow into target renovisceral vessels | Procedure | Contrast flow into the target renovisceral vessels |
| Estimated blood loss | Procedure | Estimated blood loss |
| Ventilator days | From Procedure until the date of Hospital Discharge, typically 1-2 days | Ventilator days |
| Days to oral intake | From Procedure until the date of Hospital Discharge, typically 1-2 days | Days to oral intake |
| Intensive Care Unit (ICU) days | From Procedure until the date of Hospital Discharge, typically 1-2 days | ICU days recorded |
| Days to hospital discharge | From Procedure until the date of Hospital Discharge, typically 1-2 days | Days to hospital discharge |
| Procedure time | Procedure | Procedure time (minutes) |
| Fluoroscopy time | Procedure | Fluoroscopy time (minutes) |
| Endoleak rate | 30 Days, 6 Months, and 1, 2, 3, 4, and 5 Years | Endoleak rate at 30 Days, 6 Months, and 1, 2, 3, 4, and 5 Years |
| Number of participants with device integrity failure | 30 Days, 6 Months, and 1, 2, 3, 4, and 5 Years | Device integrity failure (e.g., fracture) at 30 Days, 6 Months, and 1, 2, 3, 4, and 5 Years |
| Number of participants with branch vessel device events | 30 Days, 6 Months, and 1, 2, 3, 4, and 5 Years | Branch vessel device events (i.e., kink, stenosis, or occlusion at 30 Days, 6 Months, and 1, 2, 3, 4, and 5 Years |
| Number of participants with aortic growth | 30 Days, 6 Months, and 1, 2, 3, 4, and 5 Years | Aortic growth - defined as an increase ≥ 5 mm in maximal aortic diameter in any segment at 30 Days, 6 Months, and 1, 2, 3, 4, and 5 Years |
| Number of participants with unplanned secondary procedures | 5 Years | Unplanned secondary procedures throughout follow-up (e.g., unanticipated aortic or branch-related reoperation) |
| Number of participants with device migration | 6 Months, and 1, 2, 3, 4, and 5 Years | Device migration (radiographic), antegrade or retrograde movement of more than 10 mm relative to anatomic landmarks identified on the first (30 Day) post-operative CT scan, at 6 Months, and 1, 2, 3, 4, and 5 Years |
| All adverse events | 5 Years | All adverse events throughout 5 year follow-up, including if MAE, serious adverse event (SAE) or unanticipated adverse device effect (UADE), and the relationship of the AE to the LIFE Procedure and LIFE Device System |
| Freedom from aneurysm-related mortality | 30 Days, 6 Months, and 1, 2, 3, 4, and 5 Years | Freedom from aneurysm-related mortality at 30 Days, 6 Months, and 1, 2, 3, 4, and 5 Years |
| Freedom from all-cause mortality | 6 Months and 1, 2, 3, 4, and 5 Years | Freedom from all-cause mortality at 6 Months and 1, 2, 3, 4, and 5 Years |
Countries
United States
Contacts
CONTACTJennifer Randolph, Nurse, Clinical Research, RN, BSN
PRINCIPAL_INVESTIGATORJonathan Bath, MD
University of Missouri School - Columbia
Outcome results
None listed