iHub Stent-Graft for Iliac Artery Aneurysms: Safety, Performance, and Effectiveness Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorArcho Medical S.A
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Endovascular Iliac Branch Stent-Graft Implantation
DeviceImplantation 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Endovascular Implant of iHub Iliac Stent-Graft for Treatment of Iliac Artery AneurysmsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Absence of serious adverse events related to the device in the first month after the procedure
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.
Time frame
Within 30 days after implantationSecondary outcomes
1
Absence of surgical conversion during the follow-up period from 3 to 12 months and device performance
Absence of surgical conversion should occur during the follow-up period from 3 to 12 months and absence of leaks (endoleaks).Besides absence os incidence of serious adverse events. The study also aims to demonstrate successful delivery system positioning and accurate deployment of the stent-graft at the intended anatomical site.
Time frame
Follow-up period from 3 to 12 monthsSponsors and contacts
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Source ClinicalTrials.gov