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 is a study of a medical device already marketed (Lutonix drug coated balloon catheter) for treatment of blocked arteries below the knee (BTK). 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.
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. Projected enrolment time is 17-25months. Patient will be identified through general patient pool of hospitals using the Rutherford Category 3-5 (clinical staging system describing peripheral arterial disease) and through angiogram (imaging test using x-rays to view artery lumen). The angiogram has to be significant, ≥ 70% for native artery lesions appropriate for angioplasty (the surgical repair/procedure to unblock arteries).
Patients will undergo the standard exams and tests which are considered standard of care. The only difference from routine practice at site is; collection and analysis of patient data, patient signing an informed consent, adverse events (AEs)reporting, will be obtained and reported for each patient within follow-up windows of 1, 6, 12, and 24months after the index procedure.
Patients will undergo evaluation via telephone at 30days and 24months (or via clinical visit if preferred or as part of standard follow-up procedure) and clinical evaluation at 6 and 12months after the index procedure. Clinical visits will consist of physical examination including wound assessment, collection of current medications, and assessment of AEs. The sponsor/delegates may witness the procedure.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
15/LO/1896
Date of REC Opinion
23 Oct 2015
REC opinion
Unfavourable Opinion