|
Prostaglandin E1 (Liprostin) Treatment with Lower Limb Angioplasty for Peripheral Arterial Occlusive Disease Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Prostaglandin E1 (Liprostin) Treatment with Lower Limb Angioplasty for Peripheral Arterial Occlusive Disease conditions. Clinical Trials Search.org is a site committed 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 take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds 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 for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, 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. Subjects oftentimes recieve the most effective healthcare possible for their Prostaglandin E1 (Liprostin) Treatment with Lower Limb Angioplasty for Peripheral Arterial Occlusive Disease condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
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. Effect of Niacin Extended Release and Lovastatin tablets on Walking in Patients with Intermittent Claudication (ICPOP)
2. Trial of VLTS-589 in Subjects with Intermittent Claudication
3. Prostaglandin E1 (Liprostin) Treatment with Lower Limb Angioplasty for Peripheral Arterial Occlusive Disease
4. A safety and efficacy study of HGF via plasmid vector to improve perfusion in critical limb ischemia.
5. The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients with Intermittent Claudication - TROPIC
Related Studies:
Other Peripheral Vascular Disease Clinical Trials
Other Kentucky Clinical Trials
Other Clinical Trials
Prostaglandin E1 (Liprostin) Treatment with Lower Limb Angioplasty for Peripheral Arterial Occlusive Disease
|
|
|
|
|
|
|
|
