Prostaglandin E1 (Liprostin) Treatment With Lower Limb Angioplasty for Peripheral Arterial Occlusive Disease

Prostaglandin E1 (Liprostin) Treatment With Lower Limb Angioplasty for Peripheral Arterial Occlusive Disease

Phase II, Single Center, Non-Controlled, Open-Label Study of Liposomal Prostaglandin E1 (Liprostin) as Adjunct Therapy With Lower Limb Angioplasty in Patients With Ischemic and Non-Ischemic Peripheral Arterial Occlusive Disease

This is the first clinical research trial in which intravenous Prostaglandin E1 (PGE1 is a vasoactive hormone) will be used as supportive treatment along with the angioplasty procedure to treat or open up a blocked artery within one lower limb or the most affected of two limbs in subjects with Peripheral Arterial Occlusive Disease.

PAOD results in a decrease in arterial blood flow to the lower limb and feet with symptoms that can include, pain at rest, a numbing sensation in limb or feet, limited ability to walk before pain occurs. PAOD can occur along with diabetic ulcers. Proposed treatment will be given at a medical center with an overnight hospital stay. Treatment includes angioplasty to open up one or two occluded arteries in a lower limb plus a drug (Liprostin) a special formulation of liposomal Prostaglandin E1,or PGE1, a natural occuring vasoactive hormone). Drug treatment is given twice to each artery to be treated, just before and after angioplasty. When angioplasty procedure is completed, a 12 hour intravenous infusion of Liprostin is given to complete the treatment procedure. A total of 12 PAOD subjects will be enrolled in a single center: Memorial Hermann Hospital, Houston, TX. Study will begin in February, 2003 with the last (12th) subject to be enrolled, likely by August, 20

Inclusion Criteria: Male or female subjects, 18 years and older Diagnosis of Peripheral Arterial Occlusive Disease [PAOD] Subject is a candidate for immediate angioplasty of the lower limb Subject must complete 2 treadmill tests at Screen in which walking distance is limited by PAOD and not due to angina or fatigue Exclusion Criteria: Lower limb peripheral re-vascularization procedures in past 3 months History of myocardial infarction in the past 6 months Malignant disease, uncontrolled hypertension or Class III heart failure Aortic occlusion, thrombosed popliteal aneurysm, severe hemorrhagic disorder, or a long iliac occlusion