Biologically Modified Saphenous Vein Transplants for Improved CABG Outcomes

  • STATUS
    Recruiting
  • End date
    Nov 22, 2021
  • participants needed
    540
  • sponsor
    St. Luke's Hospital, Chesterfield, Missouri
Updated on 22 January 2021
hmg-coa reductase inhibitor

Summary

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.

Description

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

Details
Condition Atherosclerosis, Arteriosclerosis, Atherosclerotic Cardiovascular Disease
Treatment Polyarginine, Vein soak treated with Lactated Ringers Solution
Clinical Study IdentifierNCT01313533
SponsorSt. Luke's Hospital, Chesterfield, Missouri
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 25 yrs and 95 yrs?
Gender: Male or Female
Do you have Atherosclerosis?
Do you have any of these conditions: Atherosclerotic Cardiovascular Disease or Arteriosclerosis or Atherosclerosis?
Subjects must be 25-95 years of age and able to give informed consent
Use of an approved statin and anti-platelet medication for at least 24 months
Agreeable to Cardiovascular imaging at 12 months post-coronary artery bypass graft (CABG)
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

Acute traumatic injury, vasculitis or planned concurrent ventricular surgical restoration, automatic implantable cardioverter defibrillators (AICD) placement or valvular surgery
Hypercoaguable state
Comorbid illness making 2 year survival unlikely
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
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)
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
Any patient was has undergone more than 20 computerized tomography (CAT) scans
Any patient who is pregnant
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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