PSR-Coronary base
Research type
Research Study
Full title
Coronary PRODUCT SURVEILLANCE REGISTRY (PSR) PLATFORM BASE
IRAS ID
313449
Contact name
Sayan Sen
Contact email
Sponsor organisation
Medtronic
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 1 months, 31 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 Coronary products, under the PSR-Coronary protocol.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
22/YH/0128
Date of REC Opinion
17 Jun 2022
REC opinion
Favourable Opinion