Clinical Trial: Prostaglandin E1 (Liprostin) Treatment with Lower Limb Angioplasty for Peripheral Arterial Occlusive Disease


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

This study is currently recruiting patients.

Sponsored by:	Endovasc
Information provided by:	Endovasc

Purpose

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.

Condition	Treatment or Intervention	Phase
Peripheral Vascular Disease	Drug: Liprostin [liposomal Prostaglandin E1]	Phase II

MedlinePlus related topics: Circulatory Disorders

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Expanded Access Assignment, Safety/Efficacy Study

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

Further Study Details:

Expected Total Enrollment: 12

Study start: February 2003; Study completion: August 2003

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

Eligibility

Ages Eligible for Study: 18 Years - 75 Years, Genders Eligible for Study: 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

Location and Contact Information

Texas
Memorial Hermann Hospital, Houston, Texas, 77030, United States; Recruiting

Catey Carter, RN 713-500-6550 catharine.v.carter@uth.tmc.edu
Carol J Underwood, RN 713-500-6563 carol.j.underwood@uth.tmc.edu
Richard W. Smalling, M.D., Ph.D, Principal Investigator

More Information

Study ID Numbers: EV 2002-05; Limb Arterial Disease Study
Record last reviewed: March 2004
Record first received: February 4, 2003
ClinicalTrials.gov Identifier: NCT00053716
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10

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