Assessment of GORE® EXCLUDER® IBE Plus Stent Graft Performance in Patients Undergoing Endovascular Iliac Revascularization

Обзор

The IBE 25-05 study will be a prospective, non-randomized, multicenter, interventional two arm evaluation designed to assess the safety and effectiveness of the GORE® EXCLUDER® IBE Plus Stent Graft in patients with common iliac artery aneurysm (CIAA) or aorto-iliac aneurysm (AIAA) disease.

Подробное описание

The goal of this clinical trial is to evaluate the safety and effectiveness of the GORE® EXCLUDER® IBE Plus Stent Graft for endovascular revascularization in patients with common iliac artery aneurysm (CIAA) or aorto-iliac aneurysm (AIAA) disease requiring intervention. The study population includes adults aged 22 years and older, both male and infertile female, who meet specific anatomical criteria.

The main questions it aims to answer are:

Does the IBE Plus Stent Graft provide clinical benefit and maintain safety? Does the device maintain effectiveness?

Researchers will evaluate two parallel study arms:

* Primary Arm: Subjects with AIAA/CIAA pathology, including a subset newly eligible for treatment with IBE Plus. * Secondary Arm: Subjects requiring EVAR revision for previously treated AIAA/CIAA.

Participants will:

* Undergo pre-procedure assessments (informed consent, physical exam, lab tests, and CTA imaging). * Receive endovascular treatment with the IBE Plus Stent Graft. * Attend follow-up visits at 1, 6, 12, 24, 36, 48, and 60 months post-procedure for physical exams, lab tests, and imaging. * Be monitored for adverse events, device performance, and need for reintervention.

Вмешательства

• Устройство GORE® EXCLUDER® IBE Plus Stent Graft
  Endovascular aneurysm repair with the GORE® EXCLUDER® IBE Plus Stent Graft

Первичные конечные точки

• Freedom From Composite of the Following: All-Cause Mortality, Serious Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Function Decline, Conversion to Open Surgical Repair [Срок оценки: Through 30 days post-treatment]
• Freedom From Composite of the Following: IBE Plus-Related Reinterventions Involving Type Ib / Ic or Type III Endoleak, Total Occlusion of Any IBE Plus Component, Loss of Primary Patency of the Internal Iliac Device Component [Срок оценки: Through the 6 month follow-up visit]

Вторичные конечные точки (1)

• Freedom From New Onset Buttock Claudication on an IBE Plus-Treated Side [Срок оценки: Through the 6 month follow-up visit]

Критерии участия

Primary Arm Inclusion Criteria

The subject is / has:

• The target lesion and surrounding vasculature are amenable to treatment with IBE Plus system requirements:

1.1. Common iliac artery to be treated must have a common iliac diameter ≥ 25 mm with or without concomitant abdominal aortic aneurysm 1.2. Minimum diameter ≥ 12 mm within the proximal implantation zone of IBE Plus as assessed by flow lumen; calcium excluded 1.3. Intended treatment length must be ≥ 100 mm in unilateral application or a combination of ≥ 100 mm and ≥ 150 mm in bilateral application 1.4. The planned distal target landing zone within the internal iliac artery is within the trunk of the internal iliac artery with at least 15 mm of seal zone 1.5. Iliac vasculature meets anatomical specifications for selected VBX Stent Graft(s)

• Aortoiliac vasculature meets anatomical specifications for selected EXC or EXCC Devices
• Informed Consent Form (ICF) is signed by subject
• Subject is capable of complying with protocol requirements, including follow-up
• Life expectancy > 2 years
• Age ≥ 22 years at time of informed consent signature
• Male or infertile female

Secondary Arm Inclusion Criteria

The subject is / has:

• Present with any one of the following treatment indications:

1.1. The subject has a confirmed Type Ib endoleak of a previously implanted Gore EVAR device where its distal portion within the common iliac artery has a luminal diameter of at least 12 mm. Minimum diameter of ≥ 12 mm within the proximal implantation zone of IBE Plus as assessed by flow lumen; calcium excluded 1.2. The subject has documented diameter growth of the common iliac artery of at least ≥ 5 mm in the presence of a previously implanted Gore EVAR device where its distal portion within the common iliac artery has a luminal diameter of at least 12 mm. The planned distal target landing zone within the internal iliac artery is within the trunk of the internal iliac artery with at least 15 mm of seal zone

• Aortoiliac vasculature meets anatomical specifications for selected EXC or EXCC Devices
• Informed Consent Form (ICF) is signed by subject
• Subject is capable of complying with protocol requirements, including follow-up
• Life expectancy > 2 years
• Age ≥ 22 years at time of informed consent signature
• Male or infertile female

Primary Arm and Secondary Arm Exclusion Criteria

The subject is / has:

• Mycotic or ruptured aneurysm
• ASA class V (moribund patient not expected to live 24 hours with or without operation)
• Renal insufficiency defined as creatinine > 1.8 mg/dL or undergoing dialysis
• NYHA class IV
• Dissected, heavily calcified, or heavily thrombosed landing zone(s)
• Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access
• Participating in another investigational drug or medical device study within one year of study enrollment
• An active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication) that may place the patient at increased risk of endovascular infection. Subjects with a chronic infection (such as HIV, Hepatitis C, etc.) that is well controlled under their current treatment regimen may be eligible
• Degenerative connective tissue disease, e.g., Marfan's or Ehler-Danlos Syndrome
• Planned concomitant surgical procedure or major surgery within 30 days of treatment date
• History of drug abuse, e.g., cocaine or amphetamine, within 1 year of treatment
• Known sensitivities or allergies to the device materials

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07304102 · IBE 25-05

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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