Lutonix Global BTK Registry - CL0024-01_v1-04Aug2015
Research type
Research Study
Full title
A Prospective, Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon PTA Catheter for Treatment of Below-the-Knee (BTK) Arteries
IRAS ID
189922
Contact name
Ruth Proebe
Contact email
Sponsor organisation
Lutonix Inc a subsidary of Bard ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 30 days
Research summary
This registry plans to gather routine data from patient’s routine assessments treated with medical device -Lutonix drug coated balloon catheter/LUTONIX DCB. The device is used for treatment of blocked arteries below the knee. The choice of being treated with the LUTONIX DCB is based on clinical care alone, so patients do not need to be in this registry to receive treatment.
Study is intended to demonstrate the safety and access the clinical use and outcomes of the device in a worldwide patient population in clinical practice. We hope that by performing this registry we may learn how the device behaves in complex scenarios (because the registry is being performed worldwide, it allows for a wide patient selection criteria, including patients with multiple confounding complications, wide age ranges, various socioeconomic backgrounds, and differing healthcare attitudes to be observed) and we can provide valuable information to clinicians and important data for publications.Adult patients will be enrolled, presenting with claudication (cramping pain in leg induced by exercise, typically caused by obstructed arteries), or critical limb ischemia (severe blockage of arteries BTK reducing normal blood-flow). Up to 500 patients will be enrolled at up to 35 sites. The registry will last approximately 24months but individual participation in the registry would be no more than 7 days when all visits are added up. Patient will be identified through general patient pool of hospitals by clinical team.
Patients will undergo the following routine procedures e.g. imaging tests, wound assessments, will go over current medications taken, Rutherford Category 3-5 clinical staging to describe arterial disease in leg. The only difference from routine practice is; patient signing consent for us to collect and analyse their data and to collect data on all adverse events reported.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
15/LO/2102
Date of REC Opinion
30 Nov 2015
REC opinion
Favourable Opinion