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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Stephen Lee, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01272895
First received: December 28, 2010
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
Coronary Artery Disease
Device: Coronary Intervention (GENOUS stent)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Percentage stent coverage by OCT in early phases. [ Time Frame: At 2nd, 3rd, 4th, 5th, and 6th weeks after stent implantation ] [ Designated as safety issue: No ]
    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:
  • Other OCT Findings [ Time Frame: At 2nd, 3rd, 4th, 5th, and 6th week ] [ Designated as safety issue: No ]
    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.


Enrollment: 53
Study Start Date: June 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GENOUS stent Device: Coronary Intervention (GENOUS stent)
GENOUS stent (Coronary Intervention)
Other Name: EPC capturing Genous R-Stent

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01272895

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

Publications:

Responsible Party: Prof. Stephen Lee, Professor and Chief, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01272895     History of Changes
Other Study ID Numbers: UW 10-256 (IRB HKU)
Study First Received: December 28, 2010
Last Updated: February 27, 2013
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
OCT images
Stent strut coverage
Endothelialization
Neointimal thickness, area and hyperplasia
Stent malapposition

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014