Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis

Assessment of Long Term, Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: AAA - Abdominal Aortic Aneurysm

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.

• Study Type: Observational
• Enrollment (Estimated): 3500

Contacts and Locations

• Study Contact: Name: K Martin; Phone Number: 928-864-2223; Email: kgmartin@wlgore.com
• Study Contact Backup: Name: A Hoedt; Phone Number: 928-963-4445

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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 Day 30
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

Secondary Outcome Measures

Outcome Measure	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
New onset buttock claudication / erectile dysfunction	Patient reported	Time of Surgery through Year 1

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: S. Han, University of Southern California

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): September 30, 2042
• Study Completion (Estimated): September 30, 2042

Study Registration Dates

• First Submitted: January 11, 2024
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Endoprosthesis; Aneurysm; EVAR; Aortic; Endovascular; Aneurysm Repair; Aortic Repair
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: TGR 23-02AA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data to be shared will be pseudo-anonymized with subject names and birthdates removed, but information such as procedure date will not.
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: See above

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes