Biologically Modified Saphenous Vein Transplants for Improved CABG Outcomes

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01313533

Enrollment

540

Registered

2011-03-11

Start date

2015-03-31

Completion date

2021-11-30

Last updated

2019-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis

Keywords

Atherosclerosis of Autologous Vein Bypass Graft

Brief 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.

Detailed 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.

Interventions

DRUGPolyarginine

Vein soak treated with polyarginine

DRUGVein soak treated with Lactated Ringers Solution

Vein soak

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

25 Years to 95 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
To study the effects of arginine on saphenous vein graft patency rates	12 months post operation	To study the effects of arginine on saphenous vein graft patency rates

Countries

United States

Contacts

Primary ContactRonald D Leidenfrost, M.D.

drron7103@yahoo.com314-304-3049

Backup ContactRonald A Fiehler, RN

medadvant@sbcglobal.net314-434-3049

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026