AAA - Abdominal Aortic Aneurysm
Conditions
Keywords
Aneurysm, Aneurysm Repair, Endovascular, EVAR, Endoprosthesis, Aortic, Aortic Repair
Brief 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.
Detailed description
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.
Interventions
None listed
Sponsors
W.L.Gore & Associates
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements 2. Patient has been or is intended to be treated with an eligible registry device 3. Patient is age ≥ 18 years at time of informed consent signature.
Exclusion criteria
1. 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. 2. Patient with
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Characterization of remote data collection to supplement follow-up activities | Time of Surgery through Year 10 | 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 |
| New onset buttock claudication / erectile dysfunction | Time of Surgery through Year 1 | Patient reported |
Countries
Australia, Austria, Finland, Israel, Italy, Netherlands, New Zealand, Poland, Spain, Sweden, United Kingdom, United States
Contacts
CONTACTKaren Martin
CONTACTA. Lekuti
PRINCIPAL_INVESTIGATORS. Han
University of Southern California
Outcome results
None listed