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Terumo Aortic Global Endovascular Registry

Sponsor: Vascutek Ltd.

NCT ID: NCT04246463

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
Thoracic (device), Abdominal (device), Custom Device (device), Illiac Artery (device)
How long the study runs
Study runs about 131 months (dates as stated)
About the drug or intervention
Thoracic — device: Implant of a Relay stent graft system · Abdominal — device: Implant with an Anaconda or Treo Stent graft system · Custom Device — device: Implant of a Fenestrated device such as Fenestrated Anaconda or Fenestrated TREO, Relay Branch or other customised device · Illiac Artery — device: Implant with an Anaconda Iliac leg only
Patient visit burden
Not specified by the sponsor

In plain English

This registry, run by Vascutek Ltd., collects information from patients treated for abdominal and thoracic aortic aneurysms (a bulge in the body's main artery) using Terumo Aortic endovascular grafts — special tubes placed inside the artery through small cuts. Patients already taking part in an earlier registry called TREO may be able to move their data across, with approval and fresh consent.

Who can take part

  • You are old enough under your local rules (minimum age not stated — ask the trial team)
  • You need an aortic endovascular repair using a Terumo Aortic graft that is approved, CE marked, or custom-made
  • You can give informed consent (in emergencies, consent may be given afterwards or by a legal representative, if the ethics committee agrees)
  • You are willing to follow the registry plan and attend follow-up visits
  • Patients already in the TREO registry can join if the ethics committee approves and they consent again

Who may not be able to

  • You cannot or do not want to follow the study follow-up plan
  • The graft's instructions for use say you should not have it
  • You have other medical, social or psychological problems that, in the researcher's view, stop you from having the treatment or the checks before and after

What taking part involves

  • • The registry records what happens during your normal endovascular repair — it does not itself change the treatment
  • • Not stated — ask the trial team for details of exactly what is recorded

Time commitment: Not stated — ask the trial team about the number and length of follow-up visits.

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
1,000
Started
2019-12-17
Last checked
2025-07

Plain English Summary

What is this study?

  • • Testing a new treatment for abdominal aortic aneurysm
  • • Clinical study - 1,000 participants
  • • Multi-arm, multi-center, open label, prospective observational registry designed to obtain safety and performance data on the use of CE marked and custom Terumo Aortic endovascular grafts

Who can take part?

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

Where?

  • • Derby - Royal Derby Hospital
  • • Hull - Hull Royal Infirmary
  • • Manchester - Manchester Royal Infirmary
  • • Oxford - Oxford University Hospital

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

About This Trial

Multi-arm, multi-center, open label, prospective observational registry designed to obtain safety and performance data on the use of CE marked and custom Terumo Aortic endovascular grafts.

More detail

Post Market registry collecting real world, post-approval safety, performance, patient reported outcomes and health economic data on patients treated with Terumo Aortic endovascular stent-grafts in standard clinical practice.

Abdominal Aortic AneurysmThoracic Aortic AneurysmSurgery

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

  • ✓Minimum age as per local regulations
  • ✓Indication for aortic endovascular repair with an approved or CE marked by a Regulatory body or custom-made Terumo...
  • ✓Ability to provide agreement to take part
  • ✓Willingness to comply with the registry protocol
See the full criteria
Inclusion Criteria: * Minimum age as per local regulations * Indication for aortic endovascular repair with an approved or CE marked by a Regulatory body or custom-made Terumo Aortic Endovascular graft * Ability to provide informed consent o Emergent cases (typically younger patients with traumatic injuries) are not excluded if there is IRB/EC agreement to allow consent after intervention (i.e. consent to study participation, not to treatment) or use of a Legally Authorized Representative (LAR). * Willingness to comply with the registry protocol * Willingness to adhere to follow-up visits Note: Patients currently enrolled and actively participating within the TREO registry (IP-0020-16) can have their data migrated from TREO to the TiGER registry where local EC approval has been obtained and the patient has been reconsented to TiGER for longer follow-up. Exclusion Criteria: Patient is unable or unwilling to comply with the study follow-up regime. Patient is contraindicated per the IFU, or has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving treatment as well as the procedures and evaluations pre and post procedure.

Where Is This Study? (4 UK sites)

Royal Derby Hospital

Derby, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Ganesh Dr KuhanPrincipal Investigator

Hull Royal Infirmary

Hull, United Kingdom

Recruiting
Site contact (verified)
Raghuram Lakshminarayan, DRPrincipal Investigator

Manchester Royal Infirmary

Manchester, United Kingdom

Recruiting
Site contact (verified)
David Murray, MRPrincipal Investigator

Oxford University Hospital

Oxford, United Kingdom

Recruiting
Site contact (verified)
Raman Uberoi, DRPrincipal Investigator

How to Get in Touch

Michelle Durnan

Sponsor contact

CONTACT

+44 141 343 0195 m.durnan@terumoaortic.com

Sammy Jassal

Sponsor contact

CONTACT

+44 141 343 0195 s.dhaliwal@terumoaortic.com
Data sourced from ClinicalTrials.gov · Last verified: 2025-07