iHub Stent-Graft for Iliac Artery Aneurysms: Safety, Performance, and Effectiveness Study

A vizsgálat adatai

Ki végzi

Archo Medical S.A

Azonosító

NCT07005141

A regiszteradat frissítve

2026. augusztus 12.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

iHub no Tratamento de Aneurismas ilíacos: Avaliação da Segurança, Desempenho e Eficácia.

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.

Bevonási feltételek: 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; -.

Kizáró feltételek: Need for emergency surgery; Congenital abnormalities where stent placement would obstruct a major artery. Such abnormalities must be assessed prior to treatment; Contraindication to anticoagulation therapy; Diffuse atherosclerotic disease in any common iliac artery reducing its diameter to < 4 mm; 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); 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); Acute or chronic renal insufficiency (serum creatinine > 2.0 mg/dL); A dissection, rupture, or complex vascular lesion due to trauma; Contraindication to angiography; Hypercoagulable state; Life expectancy of less than one year; -.

ClinicalTrials.gov NCT07005141