Clinical trial NCT00059657: Efficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peripheral Vascular Disease
Keywords: Ecraprost in lipid emulsion
CLI
peripheral, vascular
amputation
Angioplasty
by-pass
Critical Limb Ischemia due to peripheral arterial disease
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2003-05-02
Enrollment: 280
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Critical leg ischemia (CLI) defined as distal extremity pain at rest, or peripheral ischemic ulcer(s), with severe hemodynamic impairment as diagnosed by ankle systolic pressure, toe systolic pressure or TcPO2
* Subjects will already be scheduled to receive a revascularization procedure (e.g., by-pass graft, endovascular procedure, etc.) involving a distal target artery below the knee joint (e.g., below the knee joint popliteal, anterior/posterior tibial, peroneal, plantar, pedal, etc.) as part of their normal standard of care.

Exclusion Criteria:

* Subjects with a previous major amputation (at or above ankle)
* Subjects with end stage renal disease (ESRD) defined as significant renal dysfunction evidenced by estimated creatinine clearance of \< 20 cc/min, or receiving chronic hemodialysis therapy.

Primary outcomes:
measure: Reduction in the proportion of subjects who experience a major amputation.
measure: Reduction in proportion of subjects who die within 6 months from treatment initiation.
Secondary outcomes:
measure: Reduction in major amputation rate only.
measure: Reduction in critical cardiovascular events (MI, stroke, CV death, etc.)
measure: Improvement in graft patency of index operation.
measure: Improvement in complete ulcer healing.
measure: Improvement in pain at rest.
measure: Improvement in quality of life.
measure: Improvement in hemodynamic measurements.
measure: Improvement in neuropathy.
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Glendale
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Pensacola
country: United States
state: Florida
city: Springfield
country: United States
state: Illinois
city: Shawnee Mission
country: United States
state: Kansas
city: Kenner
country: United States
state: Louisiana
city: Royal Oak
country: United States
state: Michigan
city: Biloxi
country: United States
state: Mississippi
city: Rochester
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: San Antonio
country: United States
state: Texas
city: Tacoma
country: United States
state: Washington
city: Birmingham
country: United Kingdom
city: Bristol
country: United Kingdom
city: Dundee
country: United Kingdom
city: Hull
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Southhampton
country: United Kingdom
Study officials:
References: