Biologically Modified Saphenous Vein Transplants for Improved CABG Outcomes

Atherosclerosis Clinical Trial

Official title:

Biologically Modified Saphenous Vein Transplants for Improved CABG Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01313533
• Other study ID #: R9-LRS-CS-01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 2015
• Est. completion date: November 2021

Study information

• Verified date: April 2019
• Source: St. Luke's Hospital, Chesterfield, Missouri
• Contact: Ronald D Leidenfrost, M.D.
• Phone: 314-304-3049
• Email: drron7103[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: November 2021
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Drug:
• Polyarginine
Vein soak treated with polyarginine
• Vein soak treated with Lactated Ringers Solution
Vein soak

Locations

Country	Name	City	State
United States	St. Luke's Hospital	Chesterfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
St. Luke's Hospital, Chesterfield, Missouri

Country where clinical trial is conducted

United States, 

Outcome

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