RecruitingNot Applicable

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

Brazil10 participantsStarted 2026-05-26

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Absence of serious adverse events related to the device in the first month after the procedure

Timeframe: Within 30 days after implantation

Trial details

NCT IDNCT07005141

SponsorArcho Medical S.A

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Suzan X Lima

5548988092141 regulatorio@archomedical.com

View on ClinicalTrials.gov More Iliac Aneurysm trials