PolyArginine Treated vEiN grafTs (PATENT)

• Status: Terminated
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objectives of this trial are: 1) to evaluate the safety of NONA-L-ARGININE in ex vivo application to saphenous vein segments prior to grafting; and, 2) to obtain preliminary data on the biological effects of NONA-L-ARGININE, as compared to placebo, in the prevention of neointimal hyperplasia.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lumen Therapeutics

Criteria

Inclusion Criteria:

1. Subject must be 35-85 years of age and able to give informed consent.

2. Coronary artery disease requiring bypass grafting using at least two saphenous vein bypass grafts carried out through median sternotomy and utilizing cardiopulmonary bypass.

3. Use of an approved statin anticipated for at least 24 months after surgery.

4. Subject must not be a candidate for concurrent ventricular surgical restoration, AICD placement, or valvular surgery.

5. Agreeable to CTA at 6 weeks and IVUS intervention at 12-months post-CABG. Subjects agreeable to additional CTA at 6, 12 and 24 months preferred.

Exclusion Criteria:

1. Acute traumatic injury or vasculitis.

2. Insulin-dependent diabetes.

3. Procedure is for revision for an existing bypass graft.

4. Procedure is to be minimally invasive (except for harvesting of the graft segment).

5. Concurrent cardiac valvular surgery.

6. 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 IVUS and angiography, i.e. renal failure, bleeding diathesis, or peripheral vascular disease preventing catheterization via the groin).

7. 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.

8. Subject has recent history (within past 6 months) of alcohol or drug abuse.

9. If female, subject is pregnant or trying to become pregnant.

10. Calculated creatinine clearance < 30 mls/min for non-diabetics or < 50 mls/min for non-insulin dependent diabetics.