Peripheral Vascular Disease
Conditions
Keywords
Ecraprost in lipid emulsion, CLI, peripheral, vascular, amputation, Angioplasty, by-pass, Critical Limb Ischemia due to peripheral arterial disease
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.
Interventions
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in the proportion of subjects who experience a major amputation. | — |
| Reduction in proportion of subjects who die within 6 months from treatment initiation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in graft patency of index operation. | — |
| Improvement in complete ulcer healing. | — |
| Improvement in pain at rest. | — |
| Reduction in major amputation rate only. | — |
| Improvement in hemodynamic measurements. | — |
| Improvement in neuropathy. | — |
| Improvement in quality of life. | — |
| Reduction in critical cardiovascular events (MI, stroke, CV death, etc.) | — |
Countries
United Kingdom, United States
Outcome results
None listed