Clinical Trial: OCT Evaluation of Healing of COMBO Stent

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of Neointimal Healing of Endothelial Progenitor Cell Capturing Sirolimus-Eluting (COMBO) Stent by Optical Coherence Tomography: the EGO-COMBO Pilot Study

Brief Summary: All subjects requiring percutaneous coronary intervention (PCI) and stenting are eligible to participate in the study. Restudy coronary angiogram with Optical Coherence Tomography (OCT) would be performed between 1 to 5 months at the time of a staged PCI procedure (for remaining coronary disease) or as clinically indicated, and then at 9 months. At the time of the 9-month restudy (a proper time window for drug eluting stent to develop into restenosis should it occur), any new disease detected or restenosis will be treated. The reported incidence of drug eluting stent restenosis is around 10% in simple lesions and is expected to be higher in diabetic patients, long lesions and multi-vessel diseases; a restudy at 9 months actually confers better protection to the patients with advanced disease and any restenosis can be treated timely. All data on clinical events and progress will be monitored and regular follow-ups will be carried out.

Detailed Summary:

The GENOUS Stent (the EPC Capturing R-stent, OrbusNeich Medical Inc., Fort Lauderdale, FL) is commercially available and has been extensively used in standard coronary intervention procedures treating >200 patients with critical coronary stenoses at Queen Mary Hospital. The COMBO Stent (OrbusNeich Medical Inc., Fort Lauderdale, FL) is a hybrid version of the GENOUS Stent with an abluminal sirolimus coating, and is currently under the investigational use for clinical research in the REMEDEE Study; over 20 patients have been treated and all remained in good condition since the treatment.

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. 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 a hybrid version of the GENOUS Stent, with an additional abluminal, drug eluting sirolimus coating, targeted to reduce excessive neointima formation, while maintaining the EPC capturing capacity and therefore continue to promote healing after stent injury. The hybrid function of these two technologies in this new COMBO stent is expected to produce better clinical results in terms of accelerated healing, less sten
Sponsor: Prof. Stephen Lee

Current Primary Outcome: Primary end-point: OCT findings on percentage stent strut coverage in the 2nd to the 5th months (4 monthly groups). [ Time Frame: On 2nd, 3rd, 4th, and 5th months ]

Original Primary Outcome:

• Co-primary end-points of OCT findings on early coverage (degree of endothelialization) at 3 months restudy, and OCT findings on late loss (late tissue growth, plaque volume, lumen cross sectional area) at 3-month restudy [ Time Frame: 3 months ]
  Co-primary end-points of OCT findings on early coverage (degree of endothelialization) at 3 months restudy, and OCT findings on late loss (late tissue growth, plaque volume, lumen cross sectional area) at 3-month restudy
• Co-primary end-points of OCT findings on early coverage (degree of endothelialization) at 9 months restudy, and OCT findings on late loss (late tissue growth, plaque volume, lumen cross sectional area) at 9-month restudy [ Time Frame: 9 months ]
  Co-primary end-points of OCT findings on early coverage (degree of endothelialization)at 9 months restudy, and OCT findings on late loss (late tissue growth, plaque volume, lumen cross sectional area) at 9-month restudy

Current Secondary Outcome:

• OCT findings on late loss (neointimal thickness and neointimal area) at 9 months restudy. [ Time Frame: 9 months ]
  OCT findings on late loss (neointimal thickness, neointimal area, percentage plaque volume, lumen area, and late loss in lumen area) at 9 months restudy.
• Major Adverse Cardiac Events [ Time Frame: Initial OCT follow up, 9 months follow up and one year follow up ]

  Major Adverse Cardiac Events (MACE) which defined as:

  1. Death from all cause including cardiac death
  2. Any Myocardial Infarction (Q wave and non Q-wave)

  Elevation of post-procedure CK levels to greater 2 times normal without new Q waves is considered a non Q-wave MI.

  Development of new, pathological Q waves in 2 or more contiguous leads,as assessed by the investigator and confirmed by the Clinical Endpoint Committee and elevation of cardiac enzymes. In the absence of ECG data the CEC may adjudicate Q wave MI based on the clinical scenario and appropriate cardiac enzyme data.

• Major Adverse Cardiac Events [ Time Frame: Initial OCT follow up, 9 months OCT follow up and one year follow up ]
  3. Target Lesion Revascularization requiring repeat PCI or CABG to the target lesion. Clinically driven Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis ≥50% by QCA, or revascularization of a target lesion with diameter stenosis ≥ 70% by QCA without either angina or a positive functional study.
• Any Stent Thrombosis according the Academic Research Consortium [ Time Frame: Initial OCT follow up, 9 months OCT follow up and one year follow up ]
• Stroke [ Time Frame: Initial OCT follow up, 9 months OCT follow up and one year follow up ]
  Stroke defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.
• Bleeding complication [ Time Frame: Initial OCT follow up, 9 months OCT follow up and one year follow up ]
  Bleeding complication defined as a procedure related hemorrhagic event that requires a transfusion or surgical repair. These may include a hematoma requiring treatment of retroperitoneal bleed.

Original Secondary Outcome:

• Any major adverse cardiac events at 3 months. [ Time Frame: at 3 months ]
  Any major adverse cardiac events at 3 months.
• Any major adverse cardiac events at 9 months. [ Time Frame: 9 months ]
  Any major adverse cardiac events at 9 months.

Dates:
Date Received: December 28, 2010
Date Started: October 2010
Date Completion:
Last Updated: February 27, 2013
Last Verified: February 2013