STELLAREX VASCULAR E-REGISTRY (SAVER)
Research type
Research Study
Full title
STELLAREX VASCULAR E-REGISTRY (SAVER)
IRAS ID
206564
Contact name
LAURE COUTROT
Contact email
Sponsor organisation
SPECTRANETICES
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 0 months, 1 days
Research summary
STELLAREX Vascular E-Registry is an observational clinical study called SAVER. The purpose of SAVER is to collect data on the patients treated with a drug-coated angioplasty balloon called Stellarex™ (the balloon) and assess the balloon’s performance. \n\nNeither the treatment that has been proposed nor the diagnostic and monitoring procedures for the clinical situation go beyond good medical practice. No risk, in terms of health, can be linked to the participation of the patient.\n\nPeople who participate may have leg ischemia (poor blood supply in the leg), generated by the narrowing of a blood vessel. A Balloon is used to restore the blood flow in the leg. \nThe study objective is to continue to assess the treatment by STELLARX Balloon in superficial femoral and/ or popliteal arteries according to the instructions for Use in a broad, real world, claudicant or ischemic rest pain patients population per institution’s standard practice \n\nThe balloon has been tested, approved and is commercially available in Europe \n\nThe clinical study will be conducted in up to 10000 patients at up to 330 sites throughout the world and will last around 3 years\n\nThe identity of a participant in this study will remain strictly confidential and his participation is voluntary. The subject is entitled to withdraw his consent to take part in the study for any reason, without having to justify his decision and \n\nWhen carrying out this study, medical results and personal information about the participant will be written down and processed. The data will be kept in subject medical file in which the study Doctor will document the information.\n\nAuditors, Ethics Committee, Regulatory Authorities and the sponsor and/or the sponsor’s authorised representatives may need access to the records for the purpose of checking data collected for the study\n\n\n\n
REC name
North West - Preston Research Ethics Committee
REC reference
16/NW/0435
Date of REC Opinion
17 Jun 2016
REC opinion
Further Information Favourable Opinion