Status:
TERMINATED
PolyArginine Treated vEiN grafTs (PATENT)
Lead Sponsor:
Lumen Therapeutics
Conditions:
Saphenous Vein Graft Disease
Eligibility:
All Genders
35-85 years
Phase:
PHASE1
PHASE2
Brief 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 bi...
Detailed Description
LT-1951 is an aqueous solution of NONA-L-ARGININE. The drug efficiently penetrates into vascular tissues like the saphenous vein and supplies the tissue with a sustained reservoir of L-arginine, the s...
Eligibility Criteria
Inclusion
- Subject must be 35-85 years of age and able to give informed consent.
- Coronary artery disease requiring bypass grafting using at least two saphenous vein bypass grafts carried out through median sternotomy and utilizing cardiopulmonary bypass.
- Use of an approved statin anticipated for at least 24 months after surgery.
- Subject must not be a candidate for concurrent ventricular surgical restoration, AICD placement, or valvular surgery.
- 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
- Acute traumatic injury or vasculitis.
- Insulin-dependent diabetes.
- Procedure is for revision for an existing bypass graft.
- Procedure is to be minimally invasive (except for harvesting of the graft segment).
- Concurrent cardiac valvular surgery.
- 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).
- 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.
- Subject has recent history (within past 6 months) of alcohol or drug abuse.
- If female, subject is pregnant or trying to become pregnant.
- Calculated creatinine clearance \< 30 mls/min for non-diabetics or \< 50 mls/min for non-insulin dependent diabetics.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00264706
Start Date
March 1 2005
End Date
April 1 2008
Last Update
September 8 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4