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.
Study Type
OBSERVATIONAL
Enrollment
2,000
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Central Arkansas Veteran's Healthcare System
Little Rock, Arkansas, United States
RECRUITINGUniversity of California - Irvine
Irvine, California, United States
RECRUITINGUniversity of Southern California
Los Angeles, California, United States
RECRUITINGUniversity of Southern California
Los Angeles, California, United States
RECRUITINGStanford University School of Medicine
Palo Alto, California, United States
RECRUITINGStanford University School of Medicine
Stanford, California, United States
RECRUITINGMount Sinai Vascular Institute
Miami Beach, Florida, United States
RECRUITINGUniversity of South Florida
Tampa, Florida, United States
RECRUITINGUniversity of South Florida
Tampa, Florida, United States
RECRUITINGVA Medical Center- Atlanta
Atlanta, Georgia, United States
RECRUITING...and 80 more locations
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