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IDEAL LM study

  • Research type

    Research Study

  • Full title

    Improved drug eluting stent for percutaneous coronary intervention of the left main artery in a real world all-comers population

  • IRAS ID

    162820

  • Contact name

    Keith Oldroyd

  • Contact email

    keith.oldroyd@nhs.net

  • Sponsor organisation

    Glasgow Jubilee National Hospital

  • Clinicaltrials.gov Identifier

    N/A, N/A

  • Duration of Study in the UK

    6 years, 0 months, 31 days

  • Research summary

    This is a prospective, randomized, multicenter study in patients with an indication for coronary artery revascularisation who have been accepted for percutaneous coronary intervention (PCI) of the left main coronary artery.
    818 patients of at least 18 years of age scheduled to undergo coronary artery revascularization of the left main coronary artery using PCI are planned to be included.
    Patients will be randomized in a 1:1 fashion to the Synergy stent arm or to XIENCE stent arm. Dual antiplatelet therapy (DAPT) will be stopped at t=4 months in the Synergy arm whereas in the control arm DAPT will be continued for 12 months. A subgroup of 100 patients will have control angiography with Optical Coherence Tomography (OCT) at t=3 months after treatment. OCT is a test that is carried out by using a catheter based invasive imaging system. OCT uses light rather than ultrasound and produces high resolution pictures of the coronary artery and deployed stents.
    Patients will be assessed at 3, 6, 12, 24, 36, 48 and 60 months. Total clinical follow-up will be 5 years.

  • REC name

    West Midlands - Edgbaston Research Ethics Committee

  • REC reference

    14/WM/1190

  • Date of REC Opinion

    20 Nov 2014

  • REC opinion

    Further Information Favourable Opinion