PSR-APV
Research type
Research Study
Full title
Aortic, Peripheral & Venous (APV) PRODUCT SURVEILLANCE REGISTRY (PSR) PLATFORM BASE
IRAS ID
296931
Contact name
Ian Loftus
Contact email
Sponsor organisation
Medtronic
Clinicaltrials.gov Identifier
Duration of Study in the UK
75 years, 0 months, 1 days
Research summary
The PSR registry is an ongoing record of the experience from people around the world treated with a Medtronic product and its performance. It will be used to support post-market surveillance activities and post-approval studies, e.g. to collect safety and performance information as required by regulations applicable to Medtronic.
In addition, it will be used to obtain clinical evidence for the development and improvement of medical devices, therapies, device guidelines, patient services/solutions and provide clinical data to support health economics and clinical outcomes research.
The registry is not an experimental clinical study. For this registry, we will only be collecting data, assessed in a "real-life" environment and therefore the duration of data collection will be determined by the product received by the patient.This submission is for patients who have been, or are due to be, treated with Medtronic market-approved Aortic, Peripheral and Dialysis, Embolization and Venous products, under the PSR-APV protocol.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
21/EE/0129
Date of REC Opinion
28 Jul 2021
REC opinion
Further Information Favourable Opinion