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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-001 | Other Identifier | University of Missouri |
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| Name | Class |
|---|---|
| University of Missouri-Columbia | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endovascular Aneurysm Repair | Experimental | Fenestrated Endovascular Aneurysm Repair using the LIFE Device System |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fenestrated Endovascular Aneurysm Repair using the LIFE Device System | Device | Fenestrated Endovascular Aneurysm Repair |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with freedom from death and major adverse events (MAE) | 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. | 30 days |
| Number of participants with device procedure technical success and freedom from endoleak, migration, aortic enlargement, aortic rupture, and aortic or branch-related reinterventions in | 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) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with delivery and deployment of the LIFE Device System | Ability to deliver and deploy the LIFE Device System | Procedure |
| Number of participants with delivery and deployment of the thoracic/abdominal stent graft |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Randolph, Nurse, Clinical Research, RN, BSN | Contact | 573-882-4387 | randolphjl@health.missouri.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Bath, MD | University of Missouri School - Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri - Columbia | Recruiting | Columbia | Missouri | 65212 | United States |
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| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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Prospective, single arm clinical trial
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Ability to deliver and deploy the thoracic/abdominal stent graft
| Procedure |
| Number of participants with coverage of intended aneurysm | Ability to cover the intended aneurysm | Procedure |
| Number of participants with contrast flow into target renovisceral vessels | Contrast flow into the target renovisceral vessels | Procedure |
| Estimated blood loss | Estimated blood loss | Procedure |
| Ventilator days | Ventilator days | From Procedure until the date of Hospital Discharge, typically 1-2 days |
| Days to oral intake | Days to oral intake | From Procedure until the date of Hospital Discharge, typically 1-2 days |
| Intensive Care Unit (ICU) days | ICU days recorded | From Procedure until the date of Hospital Discharge, typically 1-2 days |
| Days to hospital discharge | Days to hospital discharge | From Procedure until the date of Hospital Discharge, typically 1-2 days |
| Procedure time | Procedure time (minutes) | Procedure |
| Fluoroscopy time | Fluoroscopy time (minutes) | Procedure |
| Endoleak rate | Endoleak rate at 30 Days, 6 Months, and 1, 2, 3, 4, and 5 Years | 30 Days, 6 Months, and 1, 2, 3, 4, and 5 Years |
| Number of participants with device integrity failure | Device integrity failure (e.g., fracture) at 30 Days, 6 Months, and 1, 2, 3, 4, and 5 Years | 30 Days, 6 Months, and 1, 2, 3, 4, and 5 Years |
| Number of participants with branch vessel device events | Branch vessel device events (i.e., kink, stenosis, or occlusion at 30 Days, 6 Months, and 1, 2, 3, 4, and 5 Years | 30 Days, 6 Months, and 1, 2, 3, 4, and 5 Years |
| Number of participants with aortic growth | 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 | 30 Days, 6 Months, and 1, 2, 3, 4, and 5 Years |
| Number of participants with unplanned secondary procedures | Unplanned secondary procedures throughout follow-up (e.g., unanticipated aortic or branch-related reoperation) | 5 Years |
| Number of participants with device migration | 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 | 6 Months, and 1, 2, 3, 4, and 5 Years |
| All adverse events | 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 | 5 Years |
| Freedom from aneurysm-related mortality | Freedom from aneurysm-related mortality at 30 Days, 6 Months, and 1, 2, 3, 4, and 5 Years | 30 Days, 6 Months, and 1, 2, 3, 4, and 5 Years |
| Freedom from all-cause mortality | Freedom from all-cause mortality at 6 Months and 1, 2, 3, 4, and 5 Years | 6 Months and 1, 2, 3, 4, and 5 Years |