An observational study in AAA - Abdominal Aortic Aneurysm, sponsored by W.L.Gore & Associates. Recruiting at 90 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-05.
Sponsored by W.L.Gore & Associates · Observational
A prospective, observational post-market registry collecting outcomes through a 10-year post procedure follow-up for patients treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC Device) or the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE Device) as a part of routine clinical practice.
The purpose of the Gore Together Aortic Registry is to collect real-world data (RWD) for Gore aortic endovascular devices. Due to the nature of the program, patient selection, diagnostic imaging, and treatment interventions will be determined by physicians based on standard clinical practice. Therefore, the Sponsor will not be outlining requirements that would influence healthcare decisions.
Participants will be asked to return for regular scheduled visits as requested by their surgeon. Patients will report any issues they may have regarding the device or surgery to their surgeon/doctor.
467 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 99 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 165 across 217 observational studies indexed under Aortic Aneurysm, Abdominal.
Browse Aortic Aneurysm, Abdominal studies →W.L.Gore & Associates is the lead sponsor of 96 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Registry participants are derived from patients presenting with vascular disease that may benefit from the placement of an endovascular stent graft. The target registry population is patients who are treated with either EXCC or IBE Device at participating sites. This includes initial procedures and reinterventions (regardless of original intervention). Only patients who meet all the inclusion and none of the exclusion criteria will be included in the registry.
The registry has been designed with broad eligibility criteria to optimize the visibility of overall registry device use. An integral requirement to the target subject population is that the decision to use a GORE® EXCLUDER® product has been made prior to considering the patient for possible registry participation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients treated with the EXCC Device
Patients treated with the IBE Device
Deployment Technical Success
Successful access, delivery, and accurate deployment of the device to the intended location, and retrieval of the delivery system.
Time frame: Time of Surgery
Lesion-related Mortality
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
Time frame: Day 30 through Year 10
Lesion Rupture
Rupture in the treated segment of the vessel (e.g., aorta or branch) verified with direct observation or Computed Tomographic Angiography (CTA) scan
Time frame: Time of Surgery through Year 10
Lesion Enlargement
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
Time frame: Time of Surgery through Year 10
Endoleaks
Perfusion of a treated lesion identified through imaging analysis
Time frame: Time of Surgery through Year 10
Device Migration
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.
Time frame: Time of Surgery through Year 10
Loss of aortic / branch patency
No flow or contrast detected through the implanted aortic and/or branch component (for branched devices) confirmed with imaging and/or direct observation.
Time frame: Time of Surgery through Year 10
New onset renal failure
New onset sustained renal failure identified within 30 days of the index endovascular procedure, combined with requiring dialysis for \> 4 weeks
Time frame: Time of Surgery through Day 30
Renal function deterioration
New onset of a decrease in eGFR \> 30% following treatment when compared to baseline eGFR.
Time frame: Time of Surgery through Year 10
Device integrity events
wire fractures, stent kinking, disruption/tears in the graft component, or stent compression or invagination identified through imaging analysis
Time frame: Time of Surgery through Year 10
Reintervention
Additional surgical or interventional procedure related to the treated disease / index lesion, the registry device, or to the treatment / procedure.
Time frame: Time of Surgery through Year 10
Characterization of remote data collection to supplement follow-up activities
An exploratory description intended to assign significance to an increasingly used method of participant engagement to assess utilization, frequency by time, outcomes, contribution to total follow-up, need for elevation of care
Time frame: Time of Surgery through Year 10
New onset buttock claudication / erectile dysfunction
Patient reported
Time frame: Time of Surgery through Year 1
Plan to share: Yes — Data to be shared will be pseudo-anonymized with subject names and birthdates removed, but information such as procedure date will not.
Time frame: Sharing of IPD will not routinely be performed and is contingent on an assessment of the researcher's proposal for novelty or value in advancing educational, quality or medical practice objectives in use of this data.
Access criteria: See above
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