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
  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:


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
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

No publications provided

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:
Arterial Occlusive Diseases
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Alprostadil
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014