OCT Evaluation of Early Healing of EPC Capturing (GENOUS) Stent (EGO Study)
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      All patients who have received GENOUS stent implantation at Queen Mary Hospital for treatment
      of ischemic heart disease are eligible for this study. Those with clinical indications to
      undergo restudy coronary angiogram or staged procedure PCI will be primarily recruited into
      this study.

      Optical coherence tomography (OCT) will be performed early after stent implantation to
      evaluate vascular healing response and neointimal coverage.
    

Detailed description: 
      The GENOUS Stent is a bio-engineered 316L stainless steel coronary stent with a biocompatible
      circumferential coating of anti-CD34 antibody, and will bind to and therefore capture the
      circulatory endothelial progenitor cells (EPC) which have CD34 antigen on the surface.
      Immobilization of EPCs on the stent surface will encourage differentiation and proliferation
      of the EPCs into endothelial and neointimal layer. This stent has been used extensively in
      180 patients at Queen Mary Hospital with critical coronary stenosis.

      Animal model has demonstrated that a functional endothelial layer could be formed as soon as
      24 to 48 hours after GENOUS stent implantation (1). The HEALING-FIM registry has shown that
      GENOUS stent is clinically safe and effective in the treatment of coronary stenosis (2).
      Recent reports have further confirmed its efficacy in patients with acute coronary syndrome
      requiring urgent revascularization (3,4).

      Intracoronary frequency domain optical coherence tomography (FD-OCT) is a simple
      catheter-based imaging technique using optic fibre to achieve very detailed assessment
      (resolution down to 10 microns) of the stents, in terms of stent apposition, early neointimal
      coverage (enhanced endothelialization) and late stent neointimal growth (restenosis). It is
      performed as part of the routine cardiac catheterization procedure and provides
      high-resolution cross sectional images of the coronary arteries. OCT has been shown to be
      safe in clinical practice (5). The LightLab C7XR OCT System (Frequency Domain OCT) is a
      commercially available product with CE Mark and FDA approval, and is being used in our EGO
      Study. The Dragonfly OCT catheter used is a non-occlusive optic fibre which is extremely
      small and flexible, and will pose absolutely no additional risk to the patient under
      treatment, other than those inherent risks of a standard angioplasty procedure.

      Despite data in animal model showed a fast and complete endothelization, there is no study to
      verify and investigate on such healing benefits in human patients. Therefore, if
      endothelization and early neointimal healing benefits of the GENOUS stent can be evaluated by
      a reliable imaging technique, further studies can be carried out to extend the benefits of
      the EPC capturing capacity.
    

Intervention name(s): Coronary Intervention (GENOUS stent)
Intervention type(s): Device
Intervention description(s): GENOUS stent (Coronary Intervention)
Other intervention name(s): EPC capturing Genous R-Stent
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: OCT images; Stent strut coverage; Endothelialization; Neointimal thickness, area and hyperplasia; Stent malapposition