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

NCT07005141 | Not Yet Recruiting DMC

• 1 other identifier: 1.A.1-PRT-SRE-005.02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Iliac Aneurysm; Aortic Aneurysm, Abdominal

Keywords

iliac aneurysm; iHub; stentgraft system; endovascular treatment; abdominal aortic aneurysm; EVAR

Outcome Measures

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.

  Within 30 days after implantation

Secondary Outcomes (1)

• Absence of surgical conversion during the follow-up period from 3 to 12 months and device performance

  Follow-up period from 3 to 12 months

Study Arms (1)

Endovascular Implant of iHub Iliac Stent-Graft for Treatment of Iliac Artery Aneurysms

EXPERIMENTAL

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

Interventions

Endovascular Iliac Branch Stent-Graft Implantation DEVICE

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

Endovascular Implant of iHub Iliac Stent-Graft for Treatment of Iliac Artery Aneurysms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Archo Medical S.A: lead

Study Sites (2)

Hospital Baía Sul S/A

Florianópolis, Santa Catarina, 88020210, Brazil

Location

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

São Paulo, São Paulo, 05403-000, Brazil

Location

MeSH Terms

Conditions

Iliac Aneurysm; Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Aneurysm; Aortic Diseases

Study Officials

• Grace C Mulatti, PI

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzan X Lima

CONTACT

5548988092141; regulatorio@archomedical.com

Marcela M Dutra

CONTACT

5554898004664; mdutra.regulatorio@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 5, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2028
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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.

Locations

BR (2)