Laser In Situ Fenestration Study

N/ARecruitingNCT06411990

Jonathan Bath15 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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

ICU days recorded

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

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

Laser In Situ Fenestration Study

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts