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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC Device) | Patients treated with the EXCC Device | ||
| GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE Device) | Patients treated with the IBE Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Deployment Technical Success | Successful access, delivery, and accurate deployment of the device to the intended location, and retrieval of the delivery system. | 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 | 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 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 of Surgery through Year 10 |
| Endoleaks | Perfusion of a treated lesion identified through imaging analysis | 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 of Surgery through Year 10 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 of Surgery through Year 10 |
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Inclusion Criteria:
Exclusion Criteria:
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Registry participants are derived from patients presenting with vascular disease that may benefit from the placement of an endovascular stent graft. The target registry population is patients who are treated with either EXCC or IBE Device at participating sites. This includes initial procedures and reinterventions (regardless of original intervention). Only patients who meet all the inclusion and none of the exclusion criteria will be included in the registry.
The registry has been designed with broad eligibility criteria to optimize the visibility of overall registry device use. An integral requirement to the target subject population is that the decision to use a GORE® EXCLUDER® product has been made prior to considering the patient for possible registry participation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karen Martin | Contact | 928-864-2223 | kgmartin@wlgore.com | |
| A. Lekuti | Contact | 928-864-3576 | alekuti@wlgore.com |
| Name | Affiliation | Role |
|---|---|---|
| S. Han | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Arkansas Veteran's Healthcare System | Recruiting | Little Rock | Arkansas | 72205 | United States |
Data to be shared will be pseudo-anonymized with subject names and birthdates removed, but information such as procedure date will not.
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Sharing of IPD will not routinely be performed and is contingent on an assessment of the researcher's proposal for novelty or value in advancing educational, quality or medical practice objectives in use of this data.
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| 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. |
| 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 of Surgery through Day 30 |
| Renal function deterioration | New onset of a decrease in eGFR > 30% following treatment when compared to baseline eGFR. | 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 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 of Surgery through Year 10 |
| New onset buttock claudication / erectile dysfunction |
Patient reported |
| Time of Surgery through Year 1 |
| University of California - Irvine | Recruiting | Irvine | California | 92697 | United States |
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| University of Southern California | Recruiting | Los Angeles | California | 90033 | United States |
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| University of Southern California | Recruiting | Los Angeles | California | 90033 | United States |
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| Stanford University School of Medicine | Recruiting | Palo Alto | California | 94304 | United States |
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| Stanford University School of Medicine | Recruiting | Stanford | California | 94304 | United States |
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| Mount Sinai Vascular Institute | Recruiting | Miami Beach | Florida | 33140 | United States |
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| University of South Florida | Recruiting | Tampa | Florida | 33606 | United States |
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| University of South Florida | Recruiting | Tampa | Florida | 33606 | United States |
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| VA Medical Center- Atlanta | Recruiting | Atlanta | Georgia | 30033 | United States |
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| Emory Saint Joseph's Hospital | Recruiting | Atlanta | Georgia | 30322 | United States |
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| Augusta University Medical Center | Recruiting | Augusta | Georgia | 30912 | United States |
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| Atlanta VA Medical Center | Recruiting | Decatur | Georgia | 30033 | United States |
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| University of Chicago Hospital | Recruiting | Chicago | Illinois | 60637 | United States |
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| Endeavor Health | Recruiting | Evanston | Illinois | 60026 | United States |
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| St. Vincent Medical Group, Inc. | Recruiting | Indianapolis | Indiana | 46260 | United States |
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| University of Louisville | Recruiting | Louisville | Kentucky | 40202 | United States |
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| Our Lady of the Lake Regional Medical Center | Recruiting | Baton Rouge | Louisiana | 70808 | United States |
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| University of Maryland - Baltimore | Recruiting | Baltimore | Maryland | 21201 | United States |
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| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
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| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
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| McLaren Heatlh Care Corporation | Recruiting | Bay City | Michigan | 48708 | United States |
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| Corewell Health Medical Group West | Recruiting | Grand Rapids | Michigan | 49546 | United States |
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| Minneapolis Heart Institute Foundation | Recruiting | Minneapolis | Minnesota | 55407 | United States |
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| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
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| University of Missouri | Recruiting | Columbia | Missouri | 65212 | United States |
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| Cox Health | Recruiting | Springfield | Missouri | 65807 | United States |
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| Dartmouth Hitchcock Medical Center | Recruiting | Lebanon | New Hampshire | 03766 | United States |
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| Dartmouth Hitchcock Medical Center | Recruiting | Lebanon | New Hampshire | 03766 | United States |
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| University at Buffalo, Research Foundation | Recruiting | Buffalo | New York | 14203 | United States |
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| Mission Hospital | Recruiting | Asheville | North Carolina | 28801 | United States |
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| University of North Carolina at Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
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| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
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| Duke Universtiy Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
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| Forsyth Medical Center | Recruiting | Winston-Salem | North Carolina | 27103 | United States |
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| Wake Forest Baptist | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| Wake Forest Baptist | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| University Hospitals - Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
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| Portland VA Health Care System | Recruiting | Portland | Oregon | 97239 | United States |
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| Portland VA Health Care System | Recruiting | Portland | Oregon | 97239 | United States |
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| Hospital of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Hospital of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Prisma Health-Upstate | Recruiting | Greenville | South Carolina | 29615 | United States |
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| Prisma Health-Upstate | Recruiting | Greenville | South Carolina | 29615 | United States |
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| UT Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
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| HCA Healthcare Research Institute/Columbia Medical Center of Plano | Recruiting | Plano | Texas | 75075 | United States |
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| Baylor Scott and White | Recruiting | Plano | Texas | 75093 | United States |
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| Intermountain Health | Recruiting | Murray | Utah | 84107 | United States |
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| Intermountain Health | Recruiting | Murray | Utah | 84107 | United States |
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| University of Utah | Recruiting | Salt Lake City | Utah | 84112 | United States |
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| University of Utah | Recruiting | Salt Lake City | Utah | 84112 | United States |
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| Inova Health Care Services | Recruiting | Falls Church | Virginia | 22042 | United States |
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| Sentara Heart Hospital | Recruiting | Norfolk | Virginia | 23507 | United States |
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| Sentara Heart Hospital | Recruiting | Norfolk | Virginia | 23507 | United States |
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| CAMC Health and Education and Research Institute, Inc | Recruiting | Charleston | West Virginia | 25304 | United States |
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| Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
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| John Hunter Hospital | Not yet recruiting | New Lambton Heights | New South Wales | Australia |
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| Gold Coast Hospital and Health Services | Recruiting | Southport | Queensland | Australia |
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| Flinders Medical Centre (Vascular Unit) | Recruiting | Bedford Park | South Australia | Australia |
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| The Alfred Hospital | Recruiting | Melbourne | Victoria | Australia |
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| Royal Perth Hospital | Recruiting | Perth | Australia |
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| Royal Prince Alfred Hospital | Not yet recruiting | Sydney | Australia |
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| Medizinische Universitat Wien | Recruiting | Vienna | Austria |
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| Helsinki University Hospital (HYKS III) | Recruiting | Helsinki | Finland |
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| Helsinki University Hospital (HYKS III) | Recruiting | Helsinki | Finland |
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| Wellbeing Services County of Pirkanmaa Tampere University Hospital | Recruiting | Tampere | Finland |
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| Wellbeing Services County of Pirkanmaa | Recruiting | Tampere | Finland |
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| Tel Aviv Sourasky Medical Center | Recruiting | Tel Aviv | Israel |
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| Azienda Ospedaliero Universitaria delle Marche Ospedali Riuniti di Ancona | Recruiting | Ancona | Italy |
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| Azienda Ospedaliero Universitaria Policlinico di Bari | Recruiting | Bari | Italy |
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| Azienda Ospedaliero Universitaria Policlinico di Bari | Recruiting | Bari | Italy |
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| Fondazione IRCCS Policlinico San Matteo | Recruiting | Pavia | Italy |
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| AOU CittĂ della Salute e della Scienza di Torino Ospedale S.Giovanni Battista- Molinette | Recruiting | Torino | Italy |
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| Azienda Ospedaliera Universitaria Integrata Verona | Recruiting | Verona | Italy |
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| Amsterdam UMC Research BV | Recruiting | Amsterdam | Netherlands |
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| Stichting Elisabeth-Tweesteden Ziekenhuis | Recruiting | Tilburg | Netherlands |
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| VieCuri Medical Center | Recruiting | Venlo | Netherlands |
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| Clinical Trials New Zealand Limited - Waikato Hospital | Recruiting | Hamilton | Waikato Region | New Zealand |
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| Auckland District Health Board Charitable Trust | Recruiting | Auckland | New Zealand |
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| Uniwersytecki Szpital Kliniczny NR 1 W Lublinie | Not yet recruiting | Lublin | Poland |
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| Hospital De La Santa Creu i Sant Pau | Recruiting | Barcelona | Spain |
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| Hospital Universitario Virgen del RocĂo | Recruiting | Seville | Spain |
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| Karolinska University Hospital | Recruiting | Stockholm | Sweden |
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| Karolinska University Hospital | Recruiting | Stockholm | Sweden |
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| University Hospitals of Leicester NHS Trust | Recruiting | Leicester | United Kingdom |
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| Countess of Chester Hospital NHS Foundation Trust | Recruiting | Liverpool | United Kingdom |
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| Countess of Chester Hospital NHS Foundation Trust | Recruiting | Liverpool | United Kingdom |
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| Imperial College Healthcare NHS Trust, St. Mary's Hospital | Recruiting | London | United Kingdom |
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| St Thomas Hospital - Guys and St. Thomas' NHS | Recruiting | London | United Kingdom |
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| St Thomas Hospital - Guys and St. Thomas' NHS | Recruiting | London | United Kingdom |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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