SEATED

• Research type

  Research Study

• Full title

  Safety and Efficacy of Aneurysms Treated with Endovascular Devices

• IRAS ID

  287395

• Contact name

  Thomas Booth

• Contact email

  thomas.booth@kcl.ac.uk

• Sponsor organisation

  King’s College London

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  10 years, 0 months, 1 days

• Research summary

  Brain aneurysms (abnormal dilatations on brain blood vessels at risk of bleeding) are treated using long tubes (called “catheters”) which are navigated to the aneurysm through blood vessels, and then fill it up with “coils” (coiling). The purpose of treatment is to cut the aneurysm from the normal blood supply and reduce the risk of bleeding. Coiling (standard aneurysm treatment for over two decades) has been successful especially where the entrance to the aneurysm (the neck) is narrow as the coils do not fall out of the aneurysm into the blood vessel. Recently, novel “advanced devices” are used instead of coils, being able to treat “wide necked” aneurysms where standard coil treatment may fail. However, there is limited evidence regarding effectiveness of such devices.
  Aneurysm recurrence (failure of devices to “occlude” the aneurysm) causes are not fully understood, which if fully understood would help reduce recurrences through modification of underlying causes which can be technical or clinical.
  Many “advanced devices” initially may be marketed by companies for limited use, but then their use often expands (for example, aneurysms are treated in more locations than what was originally marketed). However, often there is a lack of evidence regarding the safety and efficacy of this expanded usage.

  After aneurysms treatment, NHS performs follow-up imaging for patients up to around 4 years with variable follow-up imaging routine (types of scans and frequency of scans) that may differ to the routines marketed by the companies. Thus, NHS use is heterogenous, and this is why our study is important.
  We aim as a comprehensive nationwide consortium to gather all the data related to “advanced devices” used for aneurysm treatment and conduct analyses to understand how effective and safe the devices are in day-to-day practice. This will be an observational study without any additional patient intervention.
  

• REC name

  Wales REC 3

• REC reference

  25/WA/0008

• Date of REC Opinion

  10 Feb 2025

• REC opinion

  Further Information Favourable Opinion