Clinical trial NCT06218875: Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis
Official title: Assessment of Long Term, Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: AAA - Abdominal Aortic Aneurysm
Keywords: Aneurysm
Aneurysm Repair
Endovascular
EVAR
Endoprosthesis
Aortic
Aortic Repair
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2024-01-23
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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 exclusion criteria required by local law.
3. 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.

Primary outcomes:
measure: Deployment Technical Success
timeFrame: Time of Surgery
measure: Lesion-related Mortality
timeFrame: Day 30 through Year 10
measure: Lesion Rupture
timeFrame: Time of Surgery through Year 10
measure: Lesion Enlargement
timeFrame: Time of Surgery through Year 10
measure: Endoleaks
timeFrame: Time of Surgery through Year 10
measure: Device Migration
timeFrame: Time of Surgery through Year 10
measure: Loss of aortic / branch patency
timeFrame: Time of Surgery through Year 10
measure: New onset renal failure
timeFrame: Time of Surgery through Day 30
measure: Renal function deterioration
timeFrame: Time of Surgery through Year 10
measure: Device integrity events
timeFrame: Time of Surgery through Year 10
measure: Reintervention
timeFrame: Time of Surgery through Year 10
Secondary outcomes:
measure: Characterization of remote data collection to supplement follow-up activities
timeFrame: Time of Surgery through Year 10
measure: New onset buttock claudication / erectile dysfunction
timeFrame: Time of Surgery through Year 1
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Central Arkansas Veteran's Healthcare System
state: Arkansas
city: Miami Beach
country: United States
facility: Mount Sinai Vascular Institute
state: Florida
city: Augusta
country: United States
facility: Augusta University Medical Center
state: Georgia
city: Indianapolis
country: United States
facility: St. Vincent Medical Group, Inc.
state: Indiana
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Regional Medical Center
state: Louisiana
city: Bay City
country: United States
facility: McLaren Heatlh Care Corporation
state: Michigan
city: Grand Rapids
country: United States
facility: Corewell Health Medical Group West
state: Michigan
city: Buffalo
country: United States
facility: University at Buffalo, Research Foundation
state: New York
city: Asheville
country: United States
facility: Mission Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Plano
country: United States
facility: HCA Healthcare Research Institute/Columbia Medical Center of Plano
state: Texas
city: Vienna
country: Austria
facility: Medizinische Universitat Wien
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria delle Marche Ospedali Riuniti di Ancona
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Torino
country: Italy
facility: AOU Città della Salute e della Scienza di Torino Ospedale S.Giovanni Battista- Molinette
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC Research BV
city: Tilburg
country: Netherlands
facility: Stichting Elisabeth-Tweesteden Ziekenhuis
city: Venlo
country: Netherlands
facility: VieCuri Medical Center
city: Barcelona
country: Spain
facility: Hospital De La Santa Creu i Sant Pau
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust, St. Mary's Hospital
Study officials:
affiliation: University of Southern California
name: S. Han
role: PRINCIPAL_INVESTIGATOR
References: