LUTONIX Global AV Registry
Research type
Research Study
Full title
Lutonix® Global AV Registry - 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 Dysfunctional AV Fistulae
IRAS ID
203431
Contact name
Ounali Jaffer
Contact email
Sponsor organisation
Lutonix Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 30 days
Research summary
This registry study involving the LUTONIX Drug Coated Balloon (DCB), has the purpose to assess the use and safety of the device in real world practice in patients presenting with clinical and hemodynamic abnormalities in native or synthetic (grafts) arteriovenous (AV) fistulae located in the arm. This means that the registry is designed to collect clinical data on a series of patients with different levels of dialysis access problems to determine device performance. The LUTONIX DCB carries the European Conformity (CE) mark (i.e., complies with the requirements of the European Union) and is commercially available on the European market. Balloon angioplasty is a common treatment option used at most hospitals to open blocked or narrowed blood vessels in the arm. The balloon of the LUTONIX DCB is coated with a drug called Paclitaxel. During inflation of the balloon in the narrowed portion of the vessel, the drug Paclitaxel is released. Paclitaxel is a well known drug that is currently used to treat various conditions, such as different cancers, for example breast cancer. In this case, it is intended to help keeping the vessel in the arm from re-narrowing over time. All procedures and exams to be performed in this registry are standard procedures. The only differences to a routine treatment are patients signing an Informed Consent Form, personal medical data relating to this registry is being collected in a database and follow-up data will be collected at 3 (phone or on-site visit), 6 (on-site) and 12 months (phone or on-site visit) to assess the patient's medical Status.
REC name
London - Brent Research Ethics Committee
REC reference
16/LO/1781
Date of REC Opinion
3 Oct 2016
REC opinion
Favourable Opinion