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NCT07005141

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

Sponsor: Archo Medical S.A

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-04

Completion Date

2028-12

Last Updated

2026-04-06

Healthy Volunteers

Conditions

Iliac Aneurysm Aortic Aneurysm, Abdominal

Interventions

DEVICE

Endovascular Iliac Branch Stent-Graft Implantation

Implantation of a self-expanding dual-lumen iliac branch stent-graft designed to treat iliac artery aneurysms while preserving perfusion to the internal iliac artery. The device enables connection to bridging stent-grafts directed to both the internal and external iliac arteries. It is compatible with previously implanted or concurrently implanted bifurcated aortic stent-grafts with branch diameters between 14 and 16 mm. The stent-graft is delivered endovascularly using a low-profile catheter-based system under fluoroscopic guidance. Once in position, the device is deployed via a controlled pull-back release mechanism. Radiopaque markers assist in precise alignment and facilitate the placement of bridging components.

Inclusion Criteria: Sign the Informed Consent Form (ICF); Are ≥ 18 years of age; Meet at least one of the following criteria for iliac artery aneurysm: 1. Common iliac artery aneurysm ≥ 25 mm in diameter; 2. Aneurysm growth of 5 mm or more within the last six months; 3. Maximum aneurysm diameter exceeds 1 to 1.5 times the normal arterial segment diameter, that is ≥ 25 mm maximum diameter; 4. Saccular aneurysm greater than 20 mm; 5. 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. \- Exclusion Criteria: 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). \-

Locations (2)

Hospital Baía Sul S/A

Florianópolis, Santa Catarina, Brazil

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP

São Paulo, São Paulo, Brazil