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

AAA - Abdominal Aortic Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06218875
• Other study ID #: TGR 23-02AA
• Status: Recruiting
• Start date: May 7, 2024
• Est. completion date: September 30, 2042

Study information

• Verified date: May 2024
• Source: W.L.Gore & Associates
• Contact: K Martin
• Phone: 928-864-2223
• Email: kgmartin[@]wlgore.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 3500
• Est. completion date: September 30, 2042
• Est. primary completion date: September 30, 2042
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• AAA - Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Locations

Country	Name	City	State
United States	Mission Hospital	Asheville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Endoleaks	Perfusion of a treated lesion identified through imaging analysis	Time of Surgery through Year 10
Primary	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
Primary	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
Primary	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
Primary	Renal function deterioration	New onset of a decrease in eGFR > 30% following treatment when compared to baseline eGFR.	Time of Surgery through Day 30
Primary	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
Primary	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	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
Secondary	New onset buttock claudication / erectile dysfunction	Patient reported	Time of Surgery through Year 1