Laser In Situ Fenestration Study (LIFE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Aneurysm; Endovascular Aneurysm Repair
• Intervention / Treatment: Device: Fenestrated Endovascular Aneurysm Repair using the LIFE Device System

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 Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nurse, Clinical Research; Phone Number: 573-882-4387; Email: randolphjl@health.missouri.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Endovascular Aneurysm Repair; Fenestrated Endovascular Aneurysm Repair using the LIFE Device System

Device: Fenestrated Endovascular Aneurysm Repair using the LIFE Device System; Fenestrated Endovascular Aneurysm Repair; Other Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Jonathan Bath
• Collaborators: University of Missouri-Columbia
• Investigators: Principal Investigator: Jonathan Bath, MD, University of Missouri School - Columbia

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2031

Study Registration Dates

• First Submitted: April 30, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Fenestrated Endovascular Aneurysm Repair
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm
• Other Study ID Numbers: 2102631; 2023-001 (Other Identifier: University of Missouri)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes