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OCT Evaluation of Early Healing of EPC Capturing (GENOUS) Stent (EGO Study) (EGO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01272895
Recruitment Status : Completed
First Posted : January 10, 2011
Last Update Posted : February 28, 2013
Information provided by (Responsible Party):
Prof. Stephen Lee, The University of Hong Kong

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Coronary Intervention (GENOUS stent) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Endothelial Progenitor Cell (EPC) Capturing (GENOUS) Stent After Coronary Stenting Utilizing Optical Coherence Tomography (OCT): the EGO Study
Study Start Date : June 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Arm Intervention/treatment
Experimental: GENOUS stent Device: Coronary Intervention (GENOUS stent)
GENOUS stent (Coronary Intervention)
Other Name: EPC capturing Genous R-Stent

Primary Outcome Measures :
  1. Percentage stent coverage by OCT in early phases. [ Time Frame: At 2nd, 3rd, 4th, 5th, and 6th weeks after stent implantation ]
    Percentage stent strut coverage at weekly intervals from 2nd to 6th week after EPC capturing stent implantation as assessed by OCT according to our OCT Early Coverage Classification.

Secondary Outcome Measures :
  1. Other OCT Findings [ Time Frame: At 2nd, 3rd, 4th, 5th, and 6th week ]
    Neointimal thickness, neointimal area, late lumen loss, and percentage strut malapposition at the time of OCT follow up observed between the 5 different weekly groups.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:-

  1. Patients aged 18-85 years old who received GENOUS stent treatment for ischemic coronary disease, and
  2. Clinically indicated for a follow-up coronary angiogram or repeated (staged) coronary interventions within 3 months.

Exclusion Criteria:-

Patients who refuse to consent to coronary angiogram or coronary angioplasty.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01272895

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Hong Kong
Division of Cardiology, Queen Mary Hospital, The University of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
Prof. Stephen Lee
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Principal Investigator: Stephen WL Lee, MD FRCP FACC Queen Mary Hospital, The University of Hong Kong

Publications of Results:

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Responsible Party: Prof. Stephen Lee, Professor and Chief, The University of Hong Kong Identifier: NCT01272895    
Other Study ID Numbers: UW 10-256 (IRB HKU)
First Posted: January 10, 2011    Key Record Dates
Last Update Posted: February 28, 2013
Last Verified: February 2013
Keywords provided by Prof. Stephen Lee, The University of Hong Kong:
OCT images
Stent strut coverage
Neointimal thickness, area and hyperplasia
Stent malapposition
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases