EGO-COMBO Angiographic Extension Study
Condition: Coronary Disease
MeSH terms: Coronary Disease
Study type: Interventional

Summary: 
      Evaluation of Endothelial ProGenitor Cell Capture Sirolimus-Eluting Stent by Optical
      Coherence Tomography: the COMBO Stent angiographic extension Study (EGO-COMBO angiographic
      extension Study)
    

Detailed description: 
      The Genous Stent (the EPC Capture R-stent, OrbusNeich Medical Inc., Fort Lauderdale, FL) is
      commercially available and has been used extensively in standard coronary intervention in the
      treatment of more than 200 patients with critical coronary stenoses at Queen Mary Hospital.
      The COMBO Stent (OrbusNeich Medical Inc., Fort Lauderdale, FL) is an improved version of the
      Genous Stent and has been implanted in 60 patients at Queen Mary Hospital. All patients have
      remained in good condition since the treatment.

      The Genous Stent is a bio-engineered 316L stainless steel coronary stent with a biocompatible
      coating having specific CD34 antibody on the inner surface. CD34 is a surface antigen present
      on circulating endothelial progenitor cell (EPC). It will be bonded to the CD34 antibody,
      resulting in capturing of the EPC onto the stent surface and differentiation into endothelial
      layer. 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).

      The COMBO Stent is developed basing on the GENOUS stent platform, and in addition, it also
      delivers a drug called sirolimus to the treated coronary blood vessel. The stent's original
      CD34 antibody coating is designed to promote healing of the coronary artery by catching
      circulating endothelial progenitor cells as they pass through the stent. These cells are
      naturally flowing in the circulation and are responsible for endothelial healing. This is
      intended to help the blood vessel wall heal over the stent more quickly and restore normal
      tissue function in the stented area. The combination of these two technologies in this new
      COMBO stent is expected to produce even better clinical results, which have been investigated
      in the previous REMEDEE Study.

      Animal study has shown the COMBO Stent promotes endothelialization and reduces neointima
      formation, as assessed by both optical coherence tomography (OCT) and histopathology (5).
      Even though COMBO Stents have been used and found to be safe in over 210 patients world-wide
      and in about 61 patients at Queen Mary Hospital under the EGO-COMBO Study Protocol, such
      beneficial endothelial coverage as assessed by OCT has never been documented in human
      subjects.

      This current EGO-COMBO angiographic extension study protocol is designed based on the
      approved protocol EGO-COMBO Study (IRB: UW 10-342). This current study mainly focuses on the
      time frame, degree of endothelialization, and the subsequent neointimal proliferation after
      COMBO Stent implantation from 2 years, as assessed by intracoronary optical coherence
      tomography (OCT).

      Intracoronary optical coherence tomography (OCT) is a simple catheter-based imaging technique
      using optic fibre to achieve very detailed assessment (resolution down to 100 microns) in
      intra-coronary stent apposition, early stent coverage (endothelialization) and late stent
      neoinitmal growth (restenosis). It is performed as part of 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 (6, 7). The C7XR OCT system (Frequency Domain
      OCT) is a commercial available product with CE Mark and FDA approval. The OCT catheter is
      just a non-occlusive optic fibre which is extremely small and flexible and will pose no
      additional risk to the patient other than those inherent risks of a standard angioplasty
      procedure.
    

Intervention name(s): The COMBO Stent
Intervention type(s): Device
Intervention description(s): The COMBO Stent is developed basing on the GENOUS stent platform, and in addition, it also delivers a drug called sirolimus to the treated coronary blood vessel. The stent's original CD34 antibody coating is designed to promote healing of the coronary artery by catching circulating endothelial progenitor cells as they pass through the stent. These cells are naturally flowing in the circulation and are responsible for endothelial healing. This is intended to help the blood vessel wall heal over the stent more quickly and restore normal tissue function in the stented area. The combination of these two technologies in this new COMBO stent is expected to produce even better clinical results, which have been investigated in the previous REMEDEE Study.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Optical Coherence Tomography; Geneous Stent; Combo Stent