PolyArginine Treated vEiN grafTs (PATENT)
NCT00264706 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2016-09-08
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.
Conditions
- Saphenous Vein Graft Disease
Interventions
- DRUG
-
Nona-L-arginine
Sponsors & Collaborators
-
Lumen Therapeutics
lead INDUSTRY
Principal Investigators
-
Stephanie Brister, M.D. · Toronto General Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 35 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-03-31
- Primary Completion
- 2008-04-30
- Completion
- 2008-04-30
Countries
- Canada
Study Locations
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