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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Endothelial Progenitor Cell (EPC) Capturing (GENOUS) Stent After Coronary Stenting Utilizing Optical Coherence Tomography (OCT): the EGO Study

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Coronary Intervention (GENOUS stent)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:- Patients aged 18-85 years old who received GENOUS stent treatment for ischemic coronary disease, and 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GENOUS stent<br> | Device: Coronary Intervention (GENOUS stent)<br>* GENOUS stent (Coronary Intervention)<br>* Other names: EPC capturing Genous R-Stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage stent coverage by OCT in early phases. | 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. | At 2nd, 3rd, 4th, 5th, and 6th weeks after stent implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other OCT Findings | 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. | At 2nd, 3rd, 4th, 5th, and 6th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCT images, Stent strut coverage, Endothelialization, Neointimal thickness, area and hyperplasia, Stent malapposition