An interventional study of Fenestrated Endovascular Aneurysm Repair using the LIFE Device System in Aortic Aneurysm and Endovascular Aneurysm Repair, sponsored by Jonathan Bath. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Jonathan Bath · Not applicable, Interventional, and Treatment
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.
222 studies on the registry are indexed under Aortic Aneurysm; 63 are open to participants now.
This study's planned enrollment of 15 is below the median of 62 across 101 interventional studies indexed under Aortic Aneurysm.
Browse Aortic Aneurysm studies →This is the only study on the registry with Jonathan Bath as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Fenestrated Endovascular Aneurysm Repair using the LIFE Device System
Device: Fenestrated Endovascular Aneurysm Repair using the LIFE Device System
Fenestrated Endovascular Aneurysm Repair
Also known as: Medtronic Valiant Thoracic Stent Graft with the Captive Delivery System, Medtronic Endurant II Stent Graft System, Medtronic Endurant IIs Stent Graft System and/or, Medtronic Endurant Aorto-uni-iliac (AUI) Stent Graft System, GORE VIABAHN VBX Balloon Expandable Endoprostheses, Spectranetics CVX-300 Excimer Laser System with the Spectranetics Turbo-Elite Laser Atherectomy Catheter
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.
Time frame: 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)
Time frame: 12 months
Number of participants with delivery and deployment of the LIFE Device System
Ability to deliver and deploy the LIFE Device System
Time frame: Procedure
Number of participants with delivery and deployment of the thoracic/abdominal stent graft
Ability to deliver and deploy the thoracic/abdominal stent graft
Time frame: Procedure
Number of participants with coverage of intended aneurysm
Ability to cover the intended aneurysm
Time frame: Procedure
Number of participants with contrast flow into target renovisceral vessels
Contrast flow into the target renovisceral vessels
Time frame: Procedure
Estimated blood loss
Estimated blood loss
Time frame: Procedure
Ventilator days
Ventilator days
Time frame: From Procedure until the date of Hospital Discharge, typically 1-2 days
Days to oral intake
Days to oral intake
Time frame: From Procedure until the date of Hospital Discharge, typically 1-2 days
Intensive Care Unit (ICU) days
ICU days recorded
Time frame: From Procedure until the date of Hospital Discharge, typically 1-2 days
Days to hospital discharge
Days to hospital discharge
Time frame: From Procedure until the date of Hospital Discharge, typically 1-2 days
Procedure time
Procedure time (minutes)
Time frame: Procedure
Fluoroscopy time
Fluoroscopy time (minutes)
Time frame: Procedure
Endoleak rate
Endoleak rate at 30 Days, 6 Months, and 1, 2, 3, 4, and 5 Years
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 Months and 1, 2, 3, 4, and 5 Years
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Jun 2028, 44 months after the start.
Of 44 interventional studies with no phase under Aortic Aneurysm, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 70. This study's planned 44 months is below that.
How these figures are worked out, and which studies are left out of them.
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