Laser In Situ Fenestration Study

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Number of participants with freedom from death and major adverse events (MAE) [Срок оценки: 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 [Срок оценки: 12 months]

Вторичные конечные точки (12)

• Number of participants with delivery and deployment of the LIFE Device System [Срок оценки: Procedure]
• Number of participants with delivery and deployment of the thoracic/abdominal stent graft [Срок оценки: Procedure]
• Number of participants with coverage of intended aneurysm [Срок оценки: Procedure]
• Number of participants with contrast flow into target renovisceral vessels [Срок оценки: Procedure]
• Estimated blood loss [Срок оценки: Procedure]
• Ventilator days [Срок оценки: From Procedure until the date of Hospital Discharge, typically 1-2 days]
• Days to oral intake [Срок оценки: From Procedure until the date of Hospital Discharge, typically 1-2 days]
• Intensive Care Unit (ICU) days [Срок оценки: From Procedure until the date of Hospital Discharge, typically 1-2 days]
• Days to hospital discharge [Срок оценки: From Procedure until the date of Hospital Discharge, typically 1-2 days]
• Procedure time [Срок оценки: Procedure]
• Fluoroscopy time [Срок оценки: Procedure]
• Endoleak rate [Срок оценки: 30 Days, 6 Months, and 1, 2, 3, 4, and 5 Years]

Критерии участия

Критерии включения

• 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.
• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Missouri - Columbia — Columbia

Идентификаторы

NCT: NCT06411990 · 2102631 · 2023-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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