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

Condition(s) targeted: Peripheral Vascular Disease

Intervention: Liprostin [liposomal Prostaglandin E1] (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Endovasc

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.

Official title: 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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Safety/Efficacy Study

Detailed description: 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

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Memorial Hermann Hospital, Houston, Texas 77030, United States; Recruiting
Catey Carter, RN, Phone: 713-500-6550, Email: catharine.v.carter@uth.tmc.edu
Carol J Underwood, RN, Phone: 713-500-6563, Email: carol.j.underwood@uth.tmc.edu
Richard W. Smalling, M.D., Ph.D, Principal Investigator

Starting date: February 2003
Ending date: August 2003
Last updated: March 6, 2007