Observational Study of GORE® EXCLUDER® Devices for Abdominal Aortic Aneurysm
This study is looking at how well the GORE® EXCLUDER® Conformable AAA Endoprosthesis or the GORE® EXCLUDER® Iliac Branch Endoprosthesis work in real-world settings for people with an abdominal aortic aneurysm (AAA), which is a bulge in the main artery that carries blood from your heart to your body. Doctors will decide your treatment as part of their usual care. The study aims to see if the device is successfully put in during surgery, and to track serious problems like death or a rupture (bursting) of the aneurysm for up to 10 years after the procedure. You can join if you are 18 or older and are being treated with one of these devices. The current recruitment status is unclear.
- Study design
- This is an observational study, meaning researchers will collect information about your treatment as part of your routine care. It plans to include 2000 participants.
- What's involved
- You will be asked to return for regular scheduled visits as requested by your surgeon. You will also report any issues you may have regarding the device or surgery to your surgeon/doctor.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 10 years after the procedure.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis
At a glance
Conditions
Where it's being run
90 sites across 41 statesStudy leadership
- S. Han · PRINCIPAL_INVESTIGATOR · University of Southern California
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Deployment Technical SuccessTime of Surgery
Successful access, delivery, and accurate deployment of the device to the intended location, and retrieval of the delivery system.
- Lesion-related MortalityDay 30 through Year 10
Death related to the index endovascular procedure, secondary procedure associated with the index lesion or the registry device, or any death where the treated disease / index lesion or registry device caused or significantly contributed to the death
- Lesion RuptureTime of Surgery through Year 10
Rupture in the treated segment of the vessel (e.g., aorta or branch) verified with direct observation or Computed Tomographic Angiography (CTA) scan
- Lesion EnlargementTime of Surgery through Year 10
An increase in maximum vessel (e.g., aorta or treated branch) diameter of \> 5 mm in the region encompassed by the initial lesion as compared to baseline using orthogonal (i.e., perpendicular to the centerline) measurements on CTA scans
- EndoleaksTime of Surgery through Year 10
Perfusion of a treated lesion identified through imaging analysis
- Device MigrationTime of Surgery through Year 10
Longitudinal movement of all or part of the device for a distance ≥ 10 mm, as confirmed by CTA scan, relative to anatomical landmarks and device positioning at the first post-operative CTA scan.
- Loss of aortic / branch patencyTime of Surgery through Year 10
No flow or contrast detected through the implanted aortic and/or branch component (for branched devices) confirmed with imaging and/or direct observation.
- New onset renal failureTime of Surgery through Day 30
New onset sustained renal failure identified within 30 days of the index endovascular procedure, combined with requiring dialysis for \> 4 weeks
- Renal function deteriorationTime of Surgery through Year 10
New onset of a decrease in eGFR \> 30% following treatment when compared to baseline eGFR.
- Device integrity eventsTime of Surgery through Year 10
wire fractures, stent kinking, disruption/tears in the graft component, or stent compression or invagination identified through imaging analysis
- ReinterventionTime of Surgery through Year 10
Additional surgical or interventional procedure related to the treated disease / index lesion, the registry device, or to the treatment / procedure.