An interventional study of Endovascular Iliac Branch Stent-Graft Implantation in Iliac Aneurysm and Aortic Aneurysm, Abdominal, sponsored by Archo Medical S.A. Recruiting at 2 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Archo Medical S.A · Not applicable, Interventional, and Treatment
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.
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
The iHub stent-graft is a low-profile device delivered via catheter for the treatment of Iliac Artery Aneurysm (IAA). The device is designed to exclude common iliac artery aneurysms while simultaneously preserving internal iliac artery perfusion.
The stent-graft consists of a single tubular component made of a self-expanding nitinol stent covered with an ePTFE film. Internally, this polymeric tube divides into two smaller tubes, measuring 9 ± 1 mm and 7 ± 1 mm in diameter, each 20 mm in length. This configuration allows the stent-graft to connect, via bridging stent-grafts, to both the internal and external iliac arteries.
For implantation, the stent-graft is compressed within a delivery system (introducer catheter), which transports the device to the target site. Once released, the stent-graft expands to its nominal diameter. The stent-grafts are manufactured in a size suitable for implantation into a main endograft branch with diameters ranging from 14 mm to 16 mm.
The stent-graft is preloaded into an introducer system, and once it reaches the intended implantation site, the device is released. During positioning, a pull-back maneuver is used to deploy the stent-graft under fluoroscopic guidance. Immediately afterward, the system's inner mandrel is removed, and the catheter then functions as an introducer sheath through which the external iliac bridging stent-graft is delivered.
The delivery system is preassembled and single-use, sterilized via ethylene oxide (EO) and validated according to ISO 11135, with sterile barrier packaging conforming to ISO 11607-1 and 11607-2.
Objectives and Expected Outcomes
To evaluate the performance of the iHub stent-graft in patients with iliac artery aneurysms. The specific objectives are:
I. To assess the safety of the iHub iliac stent-graft at 30, 90, 180, and 360 days post-implantation.
II. To evaluate the accuracy of the iHub stent-graft deployment at the intended anatomical location.
III. To assess the effectiveness of the iHub stent-graft in excluding the iliac artery aneurysm.
Primary objective is the absence of serious adverse events related to the device within 30 days following the endovascular procedure.
The secundary objective is to evaluate the performance of the iHub Stent-Graft in patients with Iliac Artery Aneurysms. Performance is defined as:
Study Design and Monitoring
This is a prospective, multicenter, first-in-human, interventional clinical investigation. Patients will undergo treatment at a qualified vascular surgery center under the oversight of a designated principal investigator (PI). The surgical team will follow a defined implant protocol, including preoperative imaging, device sizing, and procedural technique as outlined in the investigator brochure.
Monitoring of safety parameters will occur at regular intervals post-implantation through structured follow-up visits. Each follow-up includes standardized physical exams, imaging studies (ultrasound, RX and CT angiography), and laboratory testing to assess renal function.
All clinical events, including adverse events and serious adverse events (SAEs), will be tracked and categorized using standard definitions provided by ISO 14155 and Good Clinical Practice (GCP) guidelines. Data management, event adjudication, and protocol compliance monitoring will be performed by the sponsor and independent clinical monitors.
Risk Assessment and Patient Safety
The potential risks of this study include access failures, device migration, endoleaks, device fracture or infection, and cardiac, pulmonary, renal, neurological, genitourinary, sexual, thrombotic, inflammatory, anesthetic-related complications, and death. To mitigate these risks, robust qualification tests were performed on the device, quality control measures were applied during manufacturing, and experienced investigators in endovascular procedures were selected. All study personnel will receive detailed training on the protocol, device usage, and participant follow-up. A follow-up schedule, well-defined inclusion/exclusion criteria, and continuous monitoring of data and adverse events will be implemented. Safety and performance outcomes will be shared with the investigative centers throughout the study.
Ethical Considerations
The protocol was developed in compliance with ISO 14155:2020 for clinical investigation of medical devices for human subjects and follows Brazilian regulations including RDC 751/2022 , CNS 466/12 and RDC 837/2023. Ethical approval will be obtained from a local Research Ethics Committee (Comitê de Ética em Pesquisa - CEP), and all patients will sign informed consent prior to enrollment.
The consent process emphasizes voluntariness, right to withdraw at any time, and clarification of potential risks, benefits, and alternative treatments. The study complies with the ethical principles outlined in the Declaration of Helsinki.
Data Analysis and Reporting
Quantitative analysis will be performed on both safety and performance endpoints. Descriptive statistics will be used to summarize patient demographics, procedural metrics, and adverse event frequencies. Device performance will be assessed through imaging-based outcomes, including patency of the branch, endoleak classification, and aneurysm exclusion.
Any need for secondary intervention, as well as clinical symptoms such as claudication or pelvic ischemia, will be recorded. Data will be analyzed at key time points: baseline, hospital discharge, and at 90, 180, and 360 days post-procedure.
Significance and Future Directions
This study is intended to provide foundational data for future regulatory submissions. It will help determine the real-world utility and safety profile of the iHub system in the treatment of iliac aneurysms requiring internal iliac artery preservation.
If successful, the iHub may represent a valuable tool in the endovascular armamentarium, providing a lower-profile, flexible option for patients with complex iliac anatomy.
30 studies on the registry are indexed under Iliac Aneurysm; 7 are open to participants now.
This study's planned enrollment of 10 is below the median of 45 across 15 interventional studies indexed under Iliac Aneurysm.
Browse Iliac Aneurysm studies →This is the only study on the registry with Archo Medical S.A as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Sign the Form (ICF); Are ≥ 18 years of age;
Meet at least one of the following criteria for iliac artery aneurysm:
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 I to III. ASA IV patients may be included if their is greater than one year;
Are able and willing to comply with follow-up requirements during the 360-day post-implant period.
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Exclusion Criteria: Pregnant women, women of , or breastfeeding women;
A dissection, rupture, or complex vascular lesion due to trauma;
Need for emergency surgery;
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 ( ≥ 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).
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Also known as: Implantation of an Endovascular Iliac Branch Stent-Graft for Iliac Aneurysm Repair
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 implantation
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 months
Plan to share: Yes — Individual Participant Data (IPD) that underlie the results reported in this study will be shared, including: Demographic data (e.g., age, sex, baseline comorbidities) Epidemiological data relevant to the target population affected by aortoiliac aneurysms Procedural data related to technical success, including device deployment, patency, and procedural complications Clinical outcomes used to define primary and secondary success, including imaging follow-up and adverse events All collected IPD that support the assessment of primary and secondary endpoints, including freedom from endoleaks, graft patency, reintervention rates, and overall survival Technical success data, including successful access, delivery, deployment, and placement of the iHub device as per protocol
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: IPD will be available beginning 12 months after the final publication of the primary results and will remain accessible for at least 5 years.
Access criteria: Data will be available to qualified researchers upon reasonable request, subject to approval by the sponsor and compliance with data privacy regulations and applicable ethical standards.
Data sharing details ↗ · archomedical.com
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Dec 2027, 19 months after the start.
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