iHub no Tratamento de Aneurismas ilíacos: Avaliação da Segurança, Desempenho e Eficácia.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 6
- 主要终点
- Absence of serious adverse events related to the device in the first month after the procedure
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety, performance, and Preliminary effectiveness of the iHub endoprosthesis system in treating iliac artery aneurysms in adult patients requiring endovascular repair. The study population includes both male and female adults over 18 years of age who meet the inclusion criteria for endovascular treatment of iliac artery aneurysms.
The main questions it aims to answer are:
Is the iHub stent-graft system safe for use in patients with iliac artery aneurysms? Does the iHub system demonstrate adequate technical performance and sustained patency over a 12-month follow-up period? Participants will undergo a minimally invasive endovascular procedure to implant the iHub endoprosthesis system. The device is designed to preserve internal iliac artery flow while excluding the aneurysmal segment.
Participants will:
Undergo pre-screening evaluations including clinical examination, laboratory tests, and imaging (CT angiography and ultrasound).
Undergo endovascular implantation of the iHub device. Attend follow-up visits at 30, 90, 180, and 360 days post-implant to assess clinical outcomes and device performance.
详细描述
This study investigates the first-in-human use of the iHub Stent-Graft System, a vascular endoprosthesis developed to treat aneurysms in the iliac arteries with an emphasis on preserving internal iliac artery (IIA) perfusion and minimizing complications associated with pelvic ischemia. The iHub device represents an innovation in the treatment of complex aortoiliac aneurysms by offering a novel anatomical configuration and deployment strategy.
Scientific Background and Rationale
Iliac artery aneurysms (IAA), particularly those involving the common iliac artery (CIA) and extending to the internal iliac artery, pose a treatment challenge due to the anatomical and hemodynamic complexity of the pelvic vasculature. The interruption of flow to the IIA has been associated with postoperative complications such as buttock claudication, sexual dysfunction, and colonic ischemia. Therefore, preserving the IIA during endovascular aneurysm repair (EVAR) is a priority in complex iliac anatomy.
The iHub device is designed to offer a modular and flexible approach to treating iliac aneurysms, incorporating branch preservation without requiring total exclusion of the internal iliac circulation. The study addresses a significant unmet clinical need, especially in patients who are not good candidates for conventional bifurcated aortic endografts or hybrid procedures.
Device Description
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign the Informed Consent Form (ICF); Are ≥ 18 years of age;
- •Meet at least one of the following criteria for iliac artery aneurysm:
- •Common iliac artery aneurysm ≥ 25 mm in diameter;
- •Aneurysm growth of 5 mm or more within the last six months;
- •Maximum aneurysm diameter exceeds 1 to 1.5 times the normal arterial segment diameter, that is ≥ 25 mm maximum diameter;
- •Saccular aneurysm greater than 20 mm;
- •Abdominal aortic aneurysm with extension into the common iliac arteries of less than 20 mm;
- •Have a previously implanted aorto-bi-iliac stent-graft with branch diameter between 14 and 16 mm;
- •Have iliac/femoral access vessel morphology compatible with vascular access techniques, placement systems, devices, and/or accessories;
- •Are classified as ASA physical status I to III. ASA IV patients may be included if their life expectancy is greater than one year;
- •Are able and willing to comply with follow-up requirements during the 360-day post-implant period.
排除标准
- •Pregnant women, women of childbearing potential, or breastfeeding women;
- •A dissection, rupture, or complex vascular lesion due to trauma;
- •Need for emergency surgery;
- •Contraindication to angiography;
- •Diffuse atherosclerotic disease in any common iliac artery reducing its diameter to < 4 mm;
- •Congenital abnormalities where stent placement would obstruct a major artery. Such abnormalities must be assessed prior to treatment;
- •Unstable angina;
- •Class III obesity (BMI ≥ 40 kg/m²) or other clinical conditions that severely limit radiographic visualization of the aorta;
- •Connective tissue disease (e.g., Marfan or Ehlers-Danlos syndrome);
- •Hypercoagulable state;
- •Contraindication to anticoagulation therapy;
- •Acute or chronic renal insufficiency (serum creatinine > 2.0 mg/dL);
- •Life expectancy of less than one year;
- •Presence of a systemic infection that could increase the risk of endovascular device infection;
- •Known sensitivity or allergy to device materials: expanded polytetrafluoroethylene (ePTFE), fluorinated ethylene propylene (FEP), or nickel-titanium (Nitinol).
研究组 & 干预措施
Endovascular Implant of iHub Iliac Stent-Graft for Treatment of Iliac Artery Aneurysms
Eligible participants with an iliac artery aneurysm, or aneurysms of the iliac arteries, who have iliac/femoral access compatible with the delivery systems, and a previously implanted or concurrently implanted bifurcated aortic stent-graft with branch diameters between 14 and 16 mm, will undergo endovascular surgery for aneurysm treatment using the iHub device
干预措施: Endovascular Iliac Branch Stent-Graft Implantation (Device)
结局指标
主要结局
Absence of serious adverse events related to the device in the first month after the procedure
时间窗: Within 30 days after implantation
Absence of serious adverse events related to the investigational device within 30 days after implantation. These events include, but are not limited to, stent-graft migration, vessel dissection, stent-graft obstruction, occlusion of collateral vessels, type I, III, and IV endoleaks, aneurysm rupture, and intraoperative mortality.
次要结局
- Absence of surgical conversion during the follow-up period from 3 to 12 months and device performance(Follow-up period from 3 to 12 months)