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

NCT07005141 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-04-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Archo Medical S.A

    lead OTHER

Principal Investigators

  • Grace C Mulatti, PI · Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo- FMUSP

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07005141 on ClinicalTrials.gov