Clinical Trial: EGO-COMBO Clinical End-point Extension Study Beyond 36 Months

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Evaluation of Endothelial ProGenitor Cell Capture Sirolimus-Eluting Stent by Optical Coherence Tomography: the COMBO Stent 36-months Clinical End-point Extension Study (EGO-COMBO Clinical End-point Ex

Brief Summary: In this study, the safety and efficacy of COMBO TM stent beyond 36 months are assessed, in particular the occurrence of late stent thrombosis and late loss catch-up (restenosis).

Detailed Summary:

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 is now widely available for clinical use in all Hong Kong hospitals. To date, more than 300 patients in Queen Mary Hospital have received the COMBO stent as treatment for their coronary artery disease, and all of them remained stable clinically.

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 an improved version of the Genous Stent. The stent delivers a drug called sirolimus to the treated coronary blood vessel. This stent also incorporates a CD34 antibody coating that is designed to promote the healing of the treated coronary artery by catching endothelial progenitor cells from circulating blood as they pass through the stent. These cells are pro-healing and will help the blood vessel wall to heal
Sponsor: The University of Hong Kong

Current Primary Outcome: Composite Major Adverse Cardiac Events (MACE) [ Time Frame: beyond 36 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • All-cause mortality [ Time Frame: beyond 36 months ]
  • Myocardial infarction [ Time Frame: beyond 36 months ]
  • Target Lesion Revascularization [ Time Frame: beyond 36 months ]
  • Angina Class [ Time Frame: beyond 36 months ]
  • Target Vessel Failure [ Time Frame: beyond 36 months ]
  • Cardiac Death [ Time Frame: beyond 36 months ]


Original Secondary Outcome: Same as current

Information By: The University of Hong Kong

Dates:
Date Received: September 23, 2014
Date Started: September 2014
Date Completion:
Last Updated: October 7, 2014
Last Verified: October 2014