Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis
- Conditions
- AAA - Abdominal Aortic Aneurysm
- Registration Number
- NCT06218875
- Lead Sponsor
- W.L.Gore & Associates
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3500
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 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
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.
Endoleaks Time of Surgery through Year 10 Perfusion of a treated lesion identified through imaging analysis
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
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
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
Renal function deterioration Time of Surgery through Year 10 New onset of a decrease in eGFR \> 30% following treatment when compared to baseline eGFR.
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 Outcome Measures
Name Time Method New onset buttock claudication / erectile dysfunction Time of Surgery through Year 1 Patient reported
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
Trial Locations
- Locations (23)
Central Arkansas Veteran's Healthcare System
🇺🇸Little Rock, Arkansas, United States
Mount Sinai Vascular Institute
🇺🇸Miami Beach, Florida, United States
Augusta University Medical Center
🇺🇸Augusta, Georgia, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Our Lady of the Lake Regional Medical Center
🇺🇸Baton Rouge, Louisiana, United States
Corewell Health Medical Group West
🇺🇸Grand Rapids, Michigan, United States
University at Buffalo, Research Foundation
🇺🇸Buffalo, New York, United States
Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
HCA Healthcare Research Institute/Columbia Medical Center of Plano
🇺🇸Plano, Texas, United States
Azienda Ospedaliero Universitaria delle Marche Ospedali Riuniti di Ancona
🇮🇹Ancona, Italy
AOU Città della Salute e della Scienza di Torino Ospedale S.Giovanni Battista- Molinette
🇮🇹Torino, Italy
Azienda Ospedaliera Universitaria Integrata Verona
🇮🇹Verona, Italy
Amsterdam UMC Research BV
🇳🇱Amsterdam, Netherlands
Stichting Elisabeth-Tweesteden Ziekenhuis
🇳🇱Tilburg, Netherlands
Hospital De La Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
University Hospitals of Leicester NHS Trust
🇬🇧Leicester, United Kingdom
Imperial College Healthcare NHS Trust, St. Mary's Hospital
🇬🇧London, United Kingdom
St. Vincent Medical Group, Inc.
🇺🇸Indianapolis, Indiana, United States
McLaren Heatlh Care Corporation
🇺🇸Bay City, Michigan, United States
Mission Hospital
🇺🇸Asheville, North Carolina, United States
Medizinische Universitat Wien
🇦🇹Vienna, Austria
Fondazione IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy
VieCuri Medical Center
🇳🇱Venlo, Netherlands