Lutonix Global SFA Registry

• Research type

  Research Study

• Full title

  A Prospective, Global Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the LUTONIX Drug Coated PTA Dilatation Catheter

• IRAS ID

  123602

• Contact name

  Narayan Karunanithy

• Contact email

  Narayan.Karunanithy@gstt.nhs.uk

• Research summary

  Observational registry to evaluate the clinical use and safety of the Lutonix drug coated dilatation catheter. Expected recruitment will be up to 1000 patients in up to 75 sites in up to 13 countries in Europe. Subjects will be followed up at 1, 6, 12 and 24 months post procedure (though there is an option to extend consent to 5 years), via a clinic visit or a telephone contact (if the clinic visit is not part of the standard of care). There will be data collection on adverse events and medication intake only, no procedures or investigations outside of the standard of care are required for this registry. Subjects will undergo the index procedure as part of the standard medical care, there are no additional requirements.

• REC name

  London - Bromley Research Ethics Committee

• REC reference

  13/LO/1348

• Date of REC Opinion

  23 Oct 2013

• REC opinion

  Further Information Favourable Opinion