IMPACT

• Research type

  Research Study

• Full title

  IMPACT: International Post Market Product Surveillance Study of Intracranial Aneurysms Treated with an Endovascular Approach

• IRAS ID

  287493

• Contact name

  Saleh M Lamin

• Contact email

  saleh.lamin@uhb.nhs.uk

• Sponsor organisation

  Stryker Neurovascular

• Clinicaltrials.gov Identifier

  NCT04572230

• Duration of Study in the UK

  4 years, 0 months, 1 days

• Research summary

  IMPACT is an international, multicentre post market study that will recruit 200 patients across 20 sites over 4 years. The aim of this study is to collect safety and performance information on different Stryker’s Neurovascular devices used for the treatment of intracranial (within the skull) aneurysms. An aneurysm is a balloon-like enlargement of an artery resulting from a weakening of the vessel wall and may occur in any artery in the body.
  Each subject will be treated with Stryker Neurovascular (SNV) device(s) and followed up in accordance with the standard of care at each participating hospital.
  Information will be collected in accordance with the standard of care at the following timeframes:
  • Baseline (prior to treatment)
  • Procedure
  • Discharge
  • Long term follow-up per standard of care up to 24 months ( with a +/- 6 month visit window) post index aneurysm procedure.

  Information to be collected includes the following:
  • Adverse Events
  • Medications
  • Procedure/discharge
  • Imaging
  • Demographics and medical history
  • Anti-platelet Effectiveness
  • Neurological Evaluation
  • Modified Rankin Scale
  • Quality of Life
  • NIHSS – A stroke scale for evaluating impairment caused by a stroke

  The IMPACT study allows multiple device options for treatment of intracranial aneurysms. The study will allow different cohorts of subjects to be enrolled based on the device they will be treated with as per standard of care. Each study cohort will have its own objectives, and subject selection criteria. As such, every time a new cohort is added in this protocol an amendment will be submitted. The data collected during this study will provide evidence that may assist doctors in selecting an appropriate device.
  The first study cohort is EVOLVE EU, which will include data collected from subjects treated with Surpass Evolve flow diverter system device.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  21/YH/0112

• Date of REC Opinion

  9 Jul 2021

• REC opinion

  Further Information Favourable Opinion