|
Possible benefit:
|
There may or may not be medical benefit
to patients. It is hoped that results from this study will benefit
other patients with heart disease in the future. The possible benefit
of the angiography (a procedure to X-ray blood vessels) is to provide
important information about how well a vein graft is performing |
|
Purpose of trial:
|
The purpose of this multi-center Phase
III double-blind study is to test a new treatment of veins that are
used in bypass surgery. The study will evaluate whether an investigational
drug -- oligodeorynucleotide or CGT003 -- will minimize the narrowing
in vein grafts and therefore result in fewer vein graft failures and
subsequent surgeries |
|
Drug/Device being tested:
|
oligodeorynucleotide or CGT003 |
|
Sponsoring Department:
|
Surgery |
|
SIU Faculty Physician:
|
Stephen
R. Hazelrigg, M.D., Jacquelyn Quin,
M.D., Theresa Boley, R.N., M.S.N.,
A.P.N./F.N.P., Anthony Grasch,
P.A.-C. |
|
Sponsoring Company:
|
Corgentech, Inc. |
|
Number of other sites in trial:
|
100 |
|
Type of patients needed:
|
Patients undergoing bypass grafting
procedure with veins as a treatment for their coronary artery disease |
|
Age:
|
18 years and older |
|
Health status:
|
Patients with coronary artery disease
able to undergo surgery for coronary artery bypass vein grafting |
|
Number of visits required:
|
Patients will be assessed before the
surgery and then seen for follow-up visits at 30 days, six and nine
months, and once a year for five years after the surgery |
|
Length of study involvement:
|
Five years |
|
Tests to be performed:
|
The CGT003 is infused into the vein
before it is implanted in the patient. Angiography and cardiac catheterization will be performed at one
year |
|
Contact Person:
|
Theresa Boley, R.N., M.S.N., A.P.N./F.N.P.,
217-545-5000, E-Mail Address: tboley@siumed.edu |
