Bioflow III - UK & Ire Satellite Registry (CIP No: G1402)

• Research type

  Research Study

• Full title

  BIOTRONIK - Safety and Performance Registry for an all-comers patient population with the Limus Eluting Orsiro Stent System Within daily clinical practice - III (UK & Ireland Satellite)

• IRAS ID

  165083

• Contact name

  Hannah Jenkins

• Contact email

  hannah.jenkins@biotronik.com

• Clinicaltrials.gov Identifier

  NCT02257710

• Duration of Study in the UK

  2 years, 1 months, 1 days

• Research summary

  This registry is an all-comers registry for the evaluation of the
  Orsiro Limus Eluting Stent System (LESS) in daily clinical practice. It is an
  national, prospective, non-randomized, multi-center, non-interventional,
  open-label clinical evaluation. The planned number of participating sites is 5. 500 subjects will be recruited from an all-comers patient population with all subjects requiring coronary revascularisation and fulfilling the inclusion and exclusion criteria of the clinical investigation plan.
  Data will be collected at Baseline / Intervention, 6, and 12 months follow-up visits.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  15/NW/0261

• Date of REC Opinion

  24 Mar 2015

• REC opinion

  Favourable Opinion