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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2004 by Endovasc.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Endovasc

ClinicalTrials.gov Identifier:

NCT00053716

First received: February 4, 2003

Last updated: March 6, 2007

Last verified: March 2004

History of Changes

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	Intervention	Phase
Peripheral Vascular Disease	Drug: Liprostin [liposomal Prostaglandin E1]	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty Vascular Diseases

Drug Information available for: Alprostadil

U.S. FDA Resources

Further study details as provided by Endovasc:


Estimated Enrollment:	12
Study Start Date:	February 2003
Estimated Study Completion Date:	August 2003

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

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00053716

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


ClinicalTrials.gov Identifier:	NCT00053716 History of Changes
Other Study ID Numbers:	EV 2002-05 Limb Arterial Disease Study
Study First Received:	February 4, 2003
Last Updated:	March 6, 2007
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 26, 2016

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