PURPOSE:

• The purpose of this study is to determine the efficacy of graft pretreatment with CGT003, as compared to placebo, on the incidence of patients experiencing vein graft failure (i.e. at least one critical graft stenosis > 75%).

BACKGROUND: 

• Approximately 359,000 patients underwent coronary bypass procedures in the US in 1999.  Long-term studies have observed an incidence of vein graft occlusion at 19% at 1 year, 25% at 5 years, and 50% by 15 years after operation. 
• Neointimal hyperplasia, defined as the accumulation of smooth muscle cells and extracellular matrix in the intimal compartment, is the pathological process that underlies graft atherosclerosis and stenosis.
• CGT003 acts by inhibiting smooth cell proliferation and strengthening the medial layer; thus reducing graft failure.

CRITERIA FOR INCLUSION OF SUBJECTS:

• 18-80 years old
• Have CAD and be scheduled to undergo CABG that is to include at least two segments of autogenous vein
• Negative pregnancy test
• Acceptable method of birth control
• If one of the first 2400 patients enrolled, agree to have an angiogram at 12-18 months post-op

CRITERIA FOR EXCLUSION OF SUBJECTS:

• History of prior CABG
• Planned concomitant or past history of cardiac valve replacement
• Vasculitis or other non-atherosclerotic cause of CAD
• Hypercoagulable state
• Have been in another investigational drug or device study within previous 30 days
• Have been enrolled in this study for an earlier bypass; have any comorbid disease process that makes 5 year survival questionable

RECRUITMENT OF SUBJECTS: 

• Subjects will be recruited by the CVTS physicians from St. Paul University Hospital and Parkland Health and Hospital System referrals. 

For more information, please contact Nicklett Johnston, R.N. at 214-645-7728.