Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis

Condition(s) studied

Study summary

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.

Eligibility

Primary outcome measure(s)

• Deployment Technical Success — 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 — 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 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 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 of Surgery through Year 10
  Perfusion of a treated lesion identified through imaging analysis
• Device Migration — 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 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 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 of Surgery through Year 10
  New onset of a decrease in eGFR \> 30% following treatment when compared to baseline eGFR.
• Device integrity events — 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 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.

Trial sites (90)

+ 50 more sites — see the full list on the official registry below.

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