DuraGraft Registry 005-01

  • Research type

    Research Study

  • Full title

    European Multi-Center Registry to Assess Outcomes in Patients Undergoing Coronary Artery Bypass Graft Surgery: Treatment of Vascular Conduits with DuraGraft®, a Novel Endothelial Damage Inhibitor

  • IRAS ID

    220980

  • Contact name

    Vilas Satishchandran

  • Contact email

    vilas.satish@somahlution.com

  • Sponsor organisation

    Somahlution

  • Clinicaltrials.gov Identifier

    NCT02922088

  • Duration of Study in the UK

    5 years, 6 months, 1 days

  • Research summary

    DuraGraft® is a solution that is used to help preserve and protect blood vessels during coronary artery bypass grafting (CABG) surgery.

    The DuraGraft® Registry is a European registry of patients who have undergone CABG and whose vascular grafts have been treated with DuraGraft®.

    The DuraGraft Registry will collect pre-CABG intraoperative and post-operative data, major post-CABG cardiovascular adverse events, health economic outcomes and patient reported quality of life over a period of 5 years.

    This registry has been designed to collect additional medical information about the safety and performance of DuraGraft®.

  • REC name

    London - Surrey Research Ethics Committee

  • REC reference

    17/LO/0456

  • Date of REC Opinion

    12 Apr 2017

  • REC opinion

    Further Information Favourable Opinion