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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Peripheral Vascular Disease	Drug: Liprostin [liposomal Prostaglandin E1]	Phase 2

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	12 participants
Allocation:	Non-Randomized
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	February 2003
Study Completion Date :	August 2003

Arms and Interventions

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Outcome Measures

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Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Endovasc

More Information

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ClinicalTrials.gov Identifier:	NCT00053716 History of Changes
Other Study ID Numbers:	EV 2002-05; Limb Arterial Disease Study
First Posted:	February 6, 2003
Last Update Posted:	March 7, 2007
Last Verified:	March 2004

Keywords provided by Endovasc:

Angioplasty & PGE1 Treatment of Peripheral Vascular Disease

Additional relevant MeSH terms:

Vascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Arterial Occlusive Diseases; Cardiovascular Diseases; Atherosclerosis	Arteriosclerosis; Alprostadil; Platelet Aggregation Inhibitors; Vasodilator Agents; Urological Agents