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

NANot yet recruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

November 1, 2025

Primary Completion Date

November 30, 2027

Study Completion Date

November 30, 2028

Conditions
Iliac AneurysmAortic 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.

Trial Locations (2)

88020210

Hospital Baía Sul S/A, Florianópolis

05403-000

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

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Archo Medical S.A

OTHER

NCT07005141 - iHub Stent-Graft for Iliac Artery Aneurysms: Safety, Performance, and Effectiveness Study | Biotech Hunter | Biotech Hunter