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

Tracking Information
First Received Date ^ICMJE	February 4, 2003
Last Updated Date	March 6, 2007
Start Date ^ICMJE	February 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00053716 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Prostaglandin E1 (Liprostin) Treatment With Lower Limb Angioplasty for Peripheral Arterial Occlusive Disease
Official Title ^ICMJE	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
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.
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 Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Safety/Efficacy Study
Condition ^ICMJE	Peripheral Vascular Disease
Intervention ^ICMJE	Drug: Liprostin [liposomal Prostaglandin E1]
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Enrollment ^ICMJE	12
Completion Date	August 2003
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00053716
Responsible Party
Study ID Numbers ^ICMJE	EV 2002-05, Limb Arterial Disease Study
Study Sponsor ^ICMJE	Endovasc
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Endovasc
Verification Date	March 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP