Laser In Situ Fenestration Study

Aortic Aneurysm Clinical Trial

— LIFE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06411990
• Other study ID #: 2102631
• Secondary ID: 2023-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 2031

Study information

• Verified date: May 2024
• Source: University of Missouri-Columbia
• Contact: Nurse, Clinical Research
• Phone: 573-882-4387
• Email: randolphjl[@]health.missouri.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: June 2031
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm

Intervention

Device:
• Fenestrated Endovascular Aneurysm Repair using the LIFE Device System
Fenestrated Endovascular Aneurysm Repair

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Jonathan Bath	University of Missouri-Columbia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Number of participants with delivery and deployment of the LIFE Device System	Ability to deliver and deploy the LIFE Device System	Procedure
Secondary	Number of participants with delivery and deployment of the thoracic/abdominal stent graft	Ability to deliver and deploy the thoracic/abdominal stent graft	Procedure
Secondary	Number of participants with coverage of intended aneurysm	Ability to cover the intended aneurysm	Procedure
Secondary	Number of participants with contrast flow into target renovisceral vessels	Contrast flow into the target renovisceral vessels	Procedure
Secondary	Estimated blood loss	Estimated blood loss	Procedure
Secondary	Ventilator days	Ventilator days	From Procedure until the date of Hospital Discharge, typically 1-2 days
Secondary	Days to oral intake	Days to oral intake	From Procedure until the date of Hospital Discharge, typically 1-2 days
Secondary	Intensive Care Unit (ICU) days	ICU days recorded	From Procedure until the date of Hospital Discharge, typically 1-2 days
Secondary	Days to hospital discharge	Days to hospital discharge	From Procedure until the date of Hospital Discharge, typically 1-2 days
Secondary	Procedure time	Procedure time (minutes)	Procedure
Secondary	Fluoroscopy time	Fluoroscopy time (minutes)	Procedure
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of participants with unplanned secondary procedures	Unplanned secondary procedures throughout follow-up (e.g., unanticipated aortic or branch-related reoperation)	5 Years
Secondary	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
Secondary	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
Secondary	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
Secondary	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