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

    sayansen@nhs.net

  • Sponsor organisation

    Medtronic

  • Clinicaltrials.gov Identifier

    NCT01524276

  • 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