OCT guided distal cell recrossing

  • Research type

    Research Study

  • Full title

    OCT guided distal cell recrossing: a randomised comparison with angiograpy alone in bifurcational lesions treated with second generation stents

  • IRAS ID

    119950

  • Contact name

    Carlo Di Mario

  • Contact email

    C.DiMario@rbht.nhs.uk

  • Sponsor organisation

    Royal Brompton & Harefield NHS Foundation Trust

  • Research summary

    The aim of this project is to improve the treatment of complicated coronary artery disease lesions or narrowings, which specifically occur at the junction where two coronary arteries branch or diverge. This includes a main artery and a smaller side-branch artery, called a bifurcation lesion. This lesion type is commonly found in 15-20% of patients with ischemic heart disease. Although the generally accepted technique used to treat and open these narrowings is deployment of a single stent (metallic mesh-like hollow tube), there remains some technical issues with this treatment which have not yet been clarified. In this scientific study we aim to examine these through the use of Optical Coherence Tomography (OCT).
    This new imaging (scanning) light-based technique consisting of a small fibre-optic wire, allows us to acquire high resolution images of the inside lining of coronary arteries. It is performed at the same time as the Percutaneous Coronary Intervetion (PCI) procedure, taking less than 5 seconds to image an entire artery. This tool will be used to guide the best placement of stents according to two different technical approaches, in patients undergoing elective bifurcation stenting. 40 patients will be randomised into two groups. Treatment Group 1 will receive the OCT guided stenting technique. Control Group 2 will receive the non-guided or standard stenting technique followed by OCT, for observation or documentary procedural evidence only. We aim to demonstrate the difference in technical results between the two groups.
    Secondary endpoints will be the assessment of acute complications (death, myocardial infartion) and patient relevant outcomes at 1 year follow up.

  • REC name

    London - Chelsea Research Ethics Committee

  • REC reference

    13/LO/0127

  • Date of REC Opinion

    22 May 2013

  • REC opinion

    Further Information Favourable Opinion