Biologically Modified Saphenous Vein Transplants for Improved CABG Outcomes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2021-11-30

Brief Summary

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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.

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Detailed Description

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

Conditions

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Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lactated Ringers Solution with Arginine

100 ml of LRS with arginine

Group Type ACTIVE_COMPARATOR

Polyarginine

Intervention Type DRUG

Vein soak treated with polyarginine

Lactated Ringers Solution

Lactated ringers solution

Group Type PLACEBO_COMPARATOR

Vein soak treated with Lactated Ringers Solution

Intervention Type DRUG

Vein soak

Interventions

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Polyarginine

Vein soak treated with polyarginine

Intervention Type DRUG

Vein soak treated with Lactated Ringers Solution

Vein soak

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No