Efficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial Disease

Study Overview
=================
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.

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

Conditions
-----------------
Peripheral Vascular Disease

Intervention / Treatment
-----------------
* Drug: Ecraprost in lipid emulsion


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ecraprost in lipid emulsion|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CLI, Ecraprost in lipid emulsion, peripheral, vascular, amputation, Angioplasty, by-pass, Critical Limb Ischemia due to peripheral arterial disease