Efficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial Disease
Ecraprost in lipid emulsion is being developed for the treatment of Critical leg ischemia (CLI), which is the most severe form of peripheral arterial disease (PAD); This trial is designed to assess the efficacy and safety of the drug in the treatment of CLI.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of CirculaseTM in Conjunction With Peripheral Revascularization for the Treatment of Critical Leg Ischemia|
- Reduction in the proportion of subjects who experience a major amputation.
- Reduction in proportion of subjects who die within 6 months from treatment initiation.
- Reduction in major amputation rate only.
- Reduction in critical cardiovascular events (MI, stroke, CV death, etc.)
- Improvement in graft patency of index operation.
- Improvement in complete ulcer healing.
- Improvement in pain at rest.
- Improvement in quality of life.
- Improvement in hemodynamic measurements.
- Improvement in neuropathy.
|Study Start Date:||August 2001|
|Estimated Study Completion Date:||November 2005|
|United States, Arizona|
|Phoenix, Arizona, United States|
|Tucson, Arizona, United States|
|United States, California|
|Glendale, California, United States|
|Los Angeles, California, United States|
|San Francisco, California, United States|
|United States, Florida|
|Pensacola, Florida, United States|
|United States, Illinois|
|Springfield, Illinois, United States|
|United States, Kansas|
|Shawnee Mission, Kansas, United States|
|United States, Louisiana|
|Kenner, Louisiana, United States|
|United States, Michigan|
|Royal Oak, Michigan, United States|
|United States, Mississippi|
|Biloxi, Mississippi, United States|
|United States, New York|
|Rochester, New York, United States|
|United States, North Carolina|
|Durham, North Carolina, United States|
|United States, Texas|
|San Antonio, Texas, United States|
|United States, Washington|
|Tacoma, Washington, United States|
|Birmingham, United Kingdom|
|Bristol, United Kingdom|
|Dundee, United Kingdom|
|Hull, United Kingdom|
|London, United Kingdom|
|Manchester, United Kingdom|
|Southhampton, United Kingdom|