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 groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov