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

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ClinicalTrials.gov Identifier: NCT00053716
Recruitment Status : Unknown
Verified March 2004 by Endovasc.
Recruitment status was:  Recruiting
First Posted : February 6, 2003
Last Update Posted : March 7, 2007
Sponsor:
Information provided by:
Endovasc

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

Resource links provided by the National Library of Medicine

Drug Information available for: Alprostadil

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00053716


Locations
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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    
Other Study ID Numbers: EV 2002-05
Limb Arterial Disease Study
First Posted: February 6, 2003    Key Record Dates
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:
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Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Arterial Occlusive Diseases
Cardiovascular Diseases
Atherosclerosis
 Arteriosclerosis
Alprostadil
Platelet Aggregation Inhibitors
Vasodilator Agents
Urological Agents