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

Coronary Artery Disease Clinical Trial

— EGO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01272895
• Other study ID #: UW 10-256 (IRB HKU)
• Status: Completed
• Phase: Phase 4
• First received: December 28, 2010
• Last updated: February 27, 2013
• Start date: June 2010
• Est. completion date: August 2011

Study information

• Verified date: February 2013
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Coronary Intervention (GENOUS stent)
GENOUS stent (Coronary Intervention)

Locations

Country	Name	City	State
Hong Kong	Division of Cardiology, Queen Mary Hospital, The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Stephen Lee

Country where clinical trial is conducted

Hong Kong, 

References & Publications (5)

Aoki J, Serruys PW, van Beusekom H, Ong AT, McFadden EP, Sianos G, van der Giessen WJ, Regar E, de Feyter PJ, Davis HR, Rowland S, Kutryk MJ. Endothelial progenitor cell capture by stents coated with antibody against CD34: the HEALING-FIM (Healthy Endothe — View Citation

Co M, Tay E, Lee CH, Poh KK, Low A, Lim J, Lim IH, Lim YT, Tan HC. Use of endothelial progenitor cell capture stent (Genous Bio-Engineered R Stent) during primary percutaneous coronary intervention in acute myocardial infarction: intermediate- to long-ter — View Citation

Miglionico M, Patti G, D'Ambrosio A, Di Sciascio G. Percutaneous coronary intervention utilizing a new endothelial progenitor cells antibody-coated stent: a prospective single-center registry in high-risk patients. Catheter Cardiovasc Interv. 2008 Apr 1;7 — View Citation

Prati F, Cera M, Ramazzotti V, Imola F, Giudice R, Albertucci M. Safety and feasibility of a new non-occlusive technique for facilitated intracoronary optical coherence tomography (OCT) acquisition in various clinical and anatomical scenarios. EuroInterve — View Citation

Yamaguchi T, Terashima M, Akasaka T, Hayashi T, Mizuno K, Muramatsu T, Nakamura M, Nakamura S, Saito S, Takano M, Takayama T, Yoshikawa J, Suzuki T. Safety and feasibility of an intravascular optical coherence tomography image wire system in the clinical — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No