Approximately 30 patients will be enrolled in this 12-week study designed to assess the effect of continuous subcutaneous Remodulin therapy on the outcome of infrainguinal bypass grafts in patients with critical limb ischemia (CLI). Portions of the study will be conducted in the hospital and on an out-patient basis. The study will be conducted at multiple centers.

Condition	Treatment or Intervention	Phase
Peripheral Vascular Disease	Drug: Remodulin (treprostinil sodium) Injection	Phase II Phase III

Further Study Details: 

Expected Total Enrollment:  30

Ages Eligible for Study:  18 Years   -   85 Years,  Genders Eligible for Study:  Both

Criteria

• Patients with critical limb ischemia and an appropriate reference lower-limb ischemic wound due to documented peripheral arterial disease who have had an autogenous vein infrainguinal bypass graft performed immediately prior to study initiation.

Illinois
      Southern Illinois University School of Medicine, Springfield,  Illinois,  62702,  United States
Massachusetts
      University of Massachusetts Memorial Health Center, Worcester,  Massachusetts,  01655,  United States
New York
      Vascular Institute Albany Medical College, Albany,  New York,  12208,  United States
Oregon
      Oregon Health Sciences University, Portland,  Oregon,  97239,  United States

Study ID Numbers:  REM03:203
Record last reviewed:  October 2004
Last Updated:  October 22, 2004
Record first received:  August 8, 2003
ClinicalTrials.gov Identifier:  NCT00067041
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08