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Endoprosthesis

GORE® EXCLUDER® Iliac Branch Endoprosthesis for Common Iliac Artery Aneurysms

N/A
Waitlist Available
Led By Darren Schneider, MD
Research Sponsored by W.L.Gore & Associates
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 6 month follow-up visit
Awards & highlights

Study Summary

The Iliac Branch Endoprosthesis (IBE) 12-04 study will be a prospective, nonrandomized, multicenter, single-arm evaluation designed to assess the safety and efficacy of the IBE Device in subjects with common iliac artery aneurysms (CIAA) or aorto-iliac aneurysms (AIA).

Eligible Conditions
  • Common Iliac Artery Aneurysms
  • Aortoiliac Aneurysms

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 6 month follow-up visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and through 6 month follow-up visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Intestines
Freedom From: Reintervention on Iliac Branch Component (IBC) or Internal Iliac Component (IIC) Due to Type I/III Endoleak or to Re-establish Patency Due to 60% Occlusion or Greater, or Complete Loss of Blood Flow in Leg of IBC or IIC
Secondary outcome measures
Buttocks

Trial Design

1Treatment groups
Experimental Treatment
Group I: GORE® EXCLUDER® Iliac Branch EndoprosthesisExperimental Treatment1 Intervention
GORE® EXCLUDER® Iliac Branch Endoprosthesis
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GORE® EXCLUDER® Iliac Branch Endoprosthesis
2013
N/A
~70

Find a Location

Who is running the clinical trial?

W.L.Gore & AssociatesLead Sponsor
95 Previous Clinical Trials
28,119 Total Patients Enrolled
Darren Schneider, MDPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
370 Total Patients Enrolled
~5 spots leftby Jun 2025