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

Sponsor: W.L.Gore & Associates

NCT ID: NCT06218875

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 220 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor

In plain English

This study collects information from people treated for an abdominal aortic aneurysm (AAA) — a swollen, weakened area in the body's main artery in the tummy — using two W.L. Gore & Associates devices: the GORE® EXCLUDER® Conformable AAA Endoprosthesis or the Iliac Branch Endoprosthesis. These devices are placed inside the artery to treat the aneurysm. The study is run by the device maker, W.L. Gore & Associates.

Who can take part

  • Adults aged 18 or over
  • The patient (or their legal representative) gives written permission or consent
  • The patient has been treated, or is due to be treated, with one of the study devices

Who may not be able to

  • People unlikely to attend the standard follow-up check-ups set by their hospital
  • People excluded for reasons set by local law
  • People already in, or planning to join, another drug or device study within 12 months — and nobody can be in more than one part of the Together Registry at the same time

What taking part involves

  • • Not stated — ask the trial team
  • • The study records information about treatment with the two named Gore devices

Time commitment: Taking part involves being available for standard follow-up visits as set by your hospital; the number of visits and total study length are not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
2,000
Started
2024-05-07
Last checked
2026-02

Plain English Summary

What is this study?

  • • Testing a new treatment for aaa - abdominal aortic aneurysm
  • • Clinical study - 2,000 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with aaa - abdominal aortic aneurysm

Where?

  • • Leicester - University Hospitals of Leicester NHS Trust
  • • Liverpool - Countess of Chester Hospital NHS Foundation Trust
  • • Liverpool - Countess of Chester Hospital NHS Foundation Trust
  • • London - Imperial College Healthcare NHS Trust, St. Mary's Hospital
  • • +2 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

AAA - Abdominal Aortic Aneurysm

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and...
  • ✓Patient has been or is intended to be treated with an eligible registry device
  • ✓Patient is age ≥ 18 years at time of agreement to take part signature.

Who cannot take part

  • ✗Patient who is, at the time of consent, unlikely to be available for the usual treatment (SOC) follow-up visits as...
  • ✗Patient with exclusion criteria required by local law.
See the full 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.

Where Is This Study? (6 UK sites)

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Recruiting
Site contact (verified)
Gregory McMahonPrincipal Investigator

Countess of Chester Hospital NHS Foundation Trust

Liverpool, United Kingdom

Recruiting
Site contact (verified)
Leith Williams, MDPrincipal Investigator

Countess of Chester Hospital NHS Foundation Trust

Liverpool, United Kingdom

Recruiting
Site contact (verified)
Leith Williams, Mr.Principal Investigator

Imperial College Healthcare NHS Trust, St. Mary's Hospital

London, United Kingdom

Recruiting
Site contact (verified)
Colin BicknellPrincipal Investigator

St Thomas Hospital - Guys and St. Thomas' NHS

London, United Kingdom

Recruiting
Site contact (verified)
Said Abisi, MDPrincipal Investigator

St Thomas Hospital - Guys and St. Thomas' NHS

London, United Kingdom

Recruiting
Site contact (verified)
Said Abisi, M.D.Principal Investigator

How to Get in Touch

Karen Martin

Sponsor contact

CONTACT

928-864-2223 kgmartin@wlgore.com

A. Lekuti

Sponsor contact

CONTACT

928-864-3576 alekuti@wlgore.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-02