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
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