NCT06218875 · W.L.Gore & Associates
Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis
What this study is about
A forward-looking, 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.
View original scientific description
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.
Primary outcome measures
Deployment Technical Success
Time frame: Time of Surgery
Successful access, delivery, and accurate deployment of the device to the intended location, and retrieval of the delivery system.
Lesion-related Mortality
Time frame: Day 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 Rupture
Time frame: Time 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 Enlargement
Time frame: Time 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
Endoleaks
Time frame: Time of Surgery through Year 10
Perfusion of a treated lesion identified through imaging analysis
Device Migration
Time frame: Time 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 patency
Time frame: Time 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 failure
Time frame: Time 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 deterioration
Time frame: Time of Surgery through Year 10
New onset of a decrease in eGFR \> 30% following treatment when compared to baseline eGFR.
Device integrity events
Time frame: Time of Surgery through Year 10
wire fractures, stent kinking, disruption/tears in the graft component, or stent compression or invagination identified through imaging analysis
Reintervention
Time frame: Time 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements
- Patient has been or is intended to be treated with an eligible registry device
- Patient is age ≥ 18 years at time of informed consent signature.
Exclusion criteria
- Patient who is, at the time of consent, unlikely to be available for standard of care (SOC) follow-up visits as defined by the site's guidelines and procedures.
- Patient with exclusion criteria required by local law.
- Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study within 12 months of Together Registry enrollment. Subjects cannot be enrolled in another Together Registry module protocol.
Where
- Little Rock, Arkansas
- Irvine, California
- Los Angeles, California
- Palo Alto, California
- Stanford, California
- Miami Beach, Florida
- Tampa, Florida
- Atlanta, Georgia
- Augusta, Georgia
- Decatur, Georgia
- Chicago, Illinois
- Evanston, Illinois
And 29 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 5, 2026 · Source of record for eligibility and locations