Medina PMCF Study

• Research type

  Research Study

• Full title

  The MEDINA Study: MEDINA EMBOLIZATION DEVICE IN NEUROVASCULAR ANEURYSMS STUDY "A Post Market Clinical Follow-up Study"

• IRAS ID

  218277

• Contact name

  Saleh Lamin

• Contact email

  saleh.Lamin@uhb.nhs.uk

• Sponsor organisation

  Medtronic Bakken Research Center B.V.

• Clinicaltrials.gov Identifier

  NCT02982200

• Clinicaltrials.gov Identifier

  NA, NA

• Duration of Study in the UK

  4 years, 6 months, 1 days

• Research summary

  Medina PMCF Study has the purpose of assessing the performance of the Medina Embolization Device when used in unruptured and ruptured saccular intra-cranial aneurysms in a real-world, post-market setting. The device includes a self-expanding implant, a delivery wire and an introducer used to deliver the device into an off-the-shelf microcatheter. The Medina Embolization Device carries the European Conformity (CE) mark (i.e., it complies with the requirements of the European Union); the device is approved for commercialization in the countries that will be participating in this study and will be used within its intended use as specified in the approved labeling.
  Up to 280 subjects who have a saccular intra-cranial aneurysm that has not been previously treated will be enrolled at approximately 25 global centers. Subjects will be treated according to general clinical practice. After signing and Informed Consent the routine treatment is as follows: collection of personal medical data and collection of follow-up data at 42 days, 180 days, 1 year and 3 years post-procedure. The collection of data from this study will contribute towards further understanding of device performance for intra-cranial aneurysms

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  17/SC/0157

• Date of REC Opinion

  30 May 2017

• REC opinion

  Further Information Favourable Opinion