Biologically Modified Saphenous Vein Transplants for Improved CABG Outcomes



Status:Recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:25 - 95
Updated:4/6/2019
Start Date:March 2015
End Date:November 2021
Contact:Ronald D Leidenfrost, M.D.
Email:drron7103@yahoo.com
Phone:314-304-3049

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The purpose of this study is to study the effects of polyarginine treated vein grafts on
graft patency for patients undergoing coronary artery bypass surgery.

Double blind study with Lactated Ringers Solution and Lactated Ringers Solution with Arginine
soaked for 10 minutes prior to grafting on the coronary arteries.

Inclusion Criteria:

1. Subjects must be 25-95 years of age and able to give informed consent

2. Use of an approved statin and anti-platelet medication for at least 24 months.

3. Agreeable to Cardiovascular imaging at 12 months post-coronary artery bypass graft
(CABG).

4. First time coronary artery bypass surgery,redo coronary artery bypass surgery and
combined valve repair/replacement surgery and coronary artery bypass graft surgery are
eligible to participate in study.

Exclusion Criteria:

1. Acute traumatic injury, vasculitis or planned concurrent ventricular surgical
restoration, automatic implantable cardioverter defibrillators (AICD) placement or
valvular surgery.

2. Hypercoaguable state.

3. Comorbid illness making 2 year survival unlikely.

4. Participation in another interventional investigative study of a cardiovascular drug
or device within 30 days prior to CABG. May participate concurrently in other studies
where the intervention/observation will not hinder execution of this study.

5. Patients with any medical condition that, in the investigator's judgment, makes the
patient ineligible or places the patient at undue risk (e.g. conditions that preclude
standard invasive follow up procedures such as angiography, i.e. renal failure,
bleeding diathesis or peripheral vascular disease preventing catheterization via the
groin).

6. Subject has clinical evidence of infection that the Investigator deems significant to
the completion of the procedure or that could compromise the subject's safety.

7. Any patient was has undergone more than 20 computerized tomography (CAT) scans.

8. Any patient who is pregnant.
We found this trial at
1
site
Chesterfield, Missouri 63017
Phone: 314-434-3049
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mi
from
Chesterfield, MO
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