Aortic AneurysmLIFENCT06411990
Laser In Situ Fenestration Study
A study testing Fenestrated Endovascular Aneurysm Repair using the LIFE Device System in people with Aortic Aneurysm and Endovascular Aneurysm Repair, run by Jonathan Bath at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Endovascular Aneurysm Repair
- What is being tested?
- Fenestrated Endovascular Aneurysm Repair using the LIFE Device System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2024to Jun 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Endovascular aortic repair requiring coverage of renovisceral branches.
- 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.
- 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.
- Distance ≥ 5 mm between top of graft fabric and renovisceral branch orifice.
- 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.
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- Renovisceral diameter between 4 and 13 mm at the origin.
- At the time of case planning, the patient's anatomy appears amenable to complete exclusion of the aneurysm with laser fenestration techniques.
- Not willing or able to travel to sites that have access to manufacturer-made investigational endovascular devices.
- Not a candidate for currently approved endovascular options.
- 18 years or older.
- 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.
- Patient is able and willing to meet all study requirements, including participating in follow up evaluations and attending required assessment visits.
Who cannot join
- Known sensitivities or allergies to the materials of construction of the devices, including Nitinol, polyester, Platinum-Iridium, stainless steel, fluoropolymer, and heparin.
- Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed.
- Uncorrectable coagulopathy.
- Body habitus that would inhibit radiographic visualization of the aorta or exceeds the safe capacity of equipment.
- Concurrent participation in another research protocol for investigation of an experimental therapy.
- Subject has been judged to be unsuitable for participation in the study by the Investigator for any reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jennifer Randolph, Nurse, Clinical Research, RN, BSN contact
United States1 site, 1 recruiting
- Recruiting
University of Missouri - Columbia
Columbia, Missouri, 65212
Jonathan Bath, MD, (573) 882-8743, bathj@health.missouri.edu
Jennifer Randolph, RN, BSN, (573) 882-4387, randolphjl@health.missouri.edu
About this study
Official title: Laser In Situ Fenestration for Endovascular Aortic Repair (LIFE) Study
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.
Read the 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.
- Conditions
- Aortic Aneurysm, Endovascular Aneurysm Repair
- Being tested
- Fenestrated Endovascular Aneurysm Repair using the LIFE Device System
- Keywords
- Fenestrated Endovascular Aneurysm Repair
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fenestrated Endovascular Aneurysm Repair using the LIFE Device SystemDevice
Also called 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
Fenestrated Endovascular Aneurysm Repair
| Study group | Role | What they receive |
|---|---|---|
| Endovascular Aneurysm Repair | Experimental | Fenestrated Endovascular Aneurysm Repair using the LIFE Device System Receives: Device: Fenestrated Endovascular Aneurysm Repair using the LIFE Device System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 12 months
Secondary outcomes (20)
Number of participants with delivery and deployment of the LIFE Device System
Ability to deliver and deploy the LIFE Device System
Measured: Procedure
Number of participants with delivery and deployment of the thoracic/abdominal stent graft
Ability to deliver and deploy the thoracic/abdominal stent graft
Measured: Procedure
Number of participants with coverage of intended aneurysm
Ability to cover the intended aneurysm
Measured: Procedure
Number of participants with contrast flow into target renovisceral vessels
Contrast flow into the target renovisceral vessels
Measured: Procedure
Estimated blood loss
Estimated blood loss
Measured: Procedure
Ventilator days
Ventilator days
Measured: From Procedure until the date of Hospital Discharge, typically 1-2 days
Days to oral intake
Days to oral intake
Measured: From Procedure until the date of Hospital Discharge, typically 1-2 days
Intensive Care Unit (ICU) days
ICU days recorded
Measured: From Procedure until the date of Hospital Discharge, typically 1-2 days
Days to hospital discharge
Days to hospital discharge
Measured: From Procedure until the date of Hospital Discharge, typically 1-2 days
Procedure time
Procedure time (minutes)
Measured: Procedure
Fluoroscopy time
Fluoroscopy time (minutes)
Measured: Procedure
Endoleak rate
Endoleak rate at 30 Days, 6 Months, and 1, 2, 3, 4, and 5 Years
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 Months and 1, 2, 3, 4, and 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start15 Oct 2024
- Primary completionJun 2028 (estimated)
- Study completionJun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single arm clinical trial
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jonathan Bath
- Sponsor type
- University, hospital or other
- Collaborators
- University of Missouri-Columbia
- Responsible party
- Sponsor-investigator, Jonathan Bath, University of Missouri-Columbia
- Investigators
- Jonathan Bath, MD, Principal investigator, University of Missouri School - Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411990
- Sponsor's protocol ID
- 2102631
- Other IDs
- 2023-001
- Acronym
- LIFE
- Status last verified
- Sep 2026
- First submitted
- 30 Apr 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser In Situ Fenestration for Endovascular Aortic Repair (LIFE) Study
- ClinicalTrials.gov ID
- NCT06411990
- Acronym / sponsor ID
- LIFE / 2102631
- Conditions
- Aortic Aneurysm, Endovascular Aneurysm Repair
- Keywords
- Fenestrated Endovascular Aneurysm Repair
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Jonathan BathUniversity, hospital or other
- Collaborators
- University of Missouri-Columbia
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2033 (estimated)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single arm clinical trial
| Arm | Type | Receives |
|---|---|---|
| Endovascular Aneurysm Repair | Experimental | Device: Fenestrated Endovascular Aneurysm Repair using the LIFE Device SystemFenestrated Endovascular Aneurysm Repair using the LIFE Device System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
- Endovascular aortic repair requiring coverage of renovisceral branches.
- 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.
- 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.
- Distance ≥ 5 mm between top of graft fabric and renovisceral branch orifice.
Key exclusion criteria (6 listed)
- Known sensitivities or allergies to the materials of construction of the devices, including Nitinol, polyester, Platinum-Iridium, stainless steel, fluoropolymer, and heparin.
- Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed.
- Uncorrectable coagulopathy.
- Body habitus that would inhibit radiographic visualization of the aorta or exceeds the safe capacity of equipment.
- Concurrent participation in another research protocol for investigation of an experimental therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fenestrated Endovascular Aneurysm Repair using the LIFE Device SystemAlso: 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 SystemFenestrated Endovascular Aneurysm Repair | Device | Endovascular Aneurysm Repair |
Primary outcome
Number of participants with freedom from death and major adverse events (MAE)
Time frame: 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
Time frame: 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)
20 secondary outcomes
Number of participants with delivery and deployment of the LIFE Device System
Time frame: Procedure
Number of participants with delivery and deployment of the thoracic/abdominal stent graft
Time frame: Procedure
Number of participants with coverage of intended aneurysm
Time frame: Procedure
Number of participants with contrast flow into target renovisceral vessels
Time frame: Procedure
Estimated blood loss
Time frame: Procedure
Ventilator days
Time frame: From Procedure until the date of Hospital Discharge, typically 1-2 days
Days to oral intake
Time frame: From Procedure until the date of Hospital Discharge, typically 1-2 days
Intensive Care Unit (ICU) days
Time frame: From Procedure until the date of Hospital Discharge, typically 1-2 days
Days to hospital discharge
Time frame: From Procedure until the date of Hospital Discharge, typically 1-2 days
Procedure time
Time frame: Procedure
Fluoroscopy time
Time frame: Procedure
Endoleak rate
Time frame: 30 Days, 6 Months, and 1, 2, 3, 4, and 5 Years
Number of participants with device integrity failure
Time frame: 30 Days, 6 Months, and 1, 2, 3, 4, and 5 Years
Number of participants with branch vessel device events
Time frame: 30 Days, 6 Months, and 1, 2, 3, 4, and 5 Years
Number of participants with aortic growth
Time frame: 30 Days, 6 Months, and 1, 2, 3, 4, and 5 Years
Number of participants with unplanned secondary procedures
Time frame: 5 Years
Number of participants with device migration
Time frame: 6 Months, and 1, 2, 3, 4, and 5 Years
All adverse events
Time frame: 5 Years
Freedom from aneurysm-related mortality
Time frame: 30 Days, 6 Months, and 1, 2, 3, 4, and 5 Years
Freedom from all-cause mortality
Time frame: 6 Months and 1, 2, 3, 4, and 5 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Randolph, Nurse, Clinical Research, RN, BSN contact
Jonathan Bath, MD principal investigator
University of Missouri School - Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fenestrated Endovascular Aneurysm Repair using the LIFE Device System in people with Aortic Aneurysm and Endovascular Aneurysm Repair, run by Jonathan Bath at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Randolph, Nurse, Clinical Research, RN, BSN (573-882-4387, randolphjl@health.missouri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with freedom from death and major adverse events (MAE) (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.