Assessment of GORE® EXCLUDER® IBE Plus Stent Graft Performance in Patients Undergoing Endovascular Iliac Revascularization

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorW.L.Gore & Associates

About this trial

The IBE 25-05 study will be a prospective, non-randomized, multicenter, interventional two arm evaluation designed to assess the safety and effectiveness of the GORE® EXCLUDER® IBE Plus Stent Graft in patients with common iliac artery aneurysm (CIAA) or aorto-iliac aneurysm (AIAA) disease.

Eligibility criteria

Qualifiers

Aortoiliac vasculature meets anatomical specifications for selected EXC or EXCC Devices

Informed Consent Form (ICF) is signed by subject

Subject is capable of complying with protocol requirements, including follow-up

Life expectancy > 2 years

Disqualifiers

Mycotic or ruptured aneurysm

ASA class V (moribund patient not expected to live 24 hours with or without operation)

Renal insufficiency defined as creatinine > 1.8 mg/dL or undergoing dialysis

NYHA class IV

Trial design

Treatments tested in this trial

  • GORE® EXCLUDER® IBE Plus Stent Graft

Treatment groups

100 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators