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Prostaglandin E1 (Liprostin) Treatment with Lower Limb Angioplasty for Peripheral Arterial Occlusive Disease Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Prostaglandin E1 (Liprostin) Treatment with Lower Limb Angioplasty for Peripheral Arterial Occlusive Disease conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Prostaglandin E1 (Liprostin) Treatment with Lower Limb Angioplasty for Peripheral Arterial Occlusive Disease Clinical research trials and Prostaglandin E1 (Liprostin) Treatment with Lower Limb Angioplasty for Peripheral Arterial Occlusive Disease health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Prostaglandin E1 (Liprostin) Treatment with Lower Limb Angioplasty for Peripheral Arterial Occlusive Disease. Prostaglandin E1 (Liprostin) Treatment with Lower Limb Angioplasty for Peripheral Arterial Occlusive Disease Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Prostaglandin E1 (Liprostin) Treatment with Lower Limb Angioplasty for Peripheral Arterial Occlusive Disease clinical trial. Human subjects often get the best healthcare available for their Prostaglandin E1 (Liprostin) Treatment with Lower Limb Angioplasty for Peripheral Arterial Occlusive Disease condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Prostaglandin E1 (Liprostin) Treatment with Lower Limb Angioplasty for Peripheral Arterial Occlusive Disease  Prostaglandin E1 (Liprostin) Treatment with Lower Limb Angioplasty for Peripheral Arterial Occlusive Disease
Prostaglandin E1 (Liprostin) Treatment with Lower Limb Angioplasty for Peripheral Arterial Occlusive Disease
For Condition: Peripheral Vascular Disease
Status: Recruiting
Sponsor(s): Endovasc ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Expanded Access Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 12
Location and Contact Information:
Memorial Hermann Hospital *Recruiting*
Houston, Texas, 77030
United States
Recruiting Catey Carter 713-500-6550
Additional Information:
Study ID Numbers: EV 2002-05; Limb Arterial Disease Study
Study Start Date: February 2003
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00053716
Other Peripheral Vascular Disease Studies:
1. The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients with Intermittent Claudication - TROPIC
2. A safety and efficacy study of HGF via plasmid vector to improve perfusion in critical limb ischemia.
3. Prostaglandin E1 (Liprostin) Treatment with Lower Limb Angioplasty for Peripheral Arterial Occlusive Disease
4. Trial of VLTS-589 in Subjects with Intermittent Claudication
5. Extract of Ginkgo Biloba (EGB 761) and Vascular Function
Related Studies:
Other Peripheral Vascular Disease Clinical Trials
Other Maryland Clinical Trials
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Prostaglandin E1 (Liprostin) Treatment with Lower Limb Angioplasty for Peripheral Arterial Occlusive Disease
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