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Prostaglandin E1 (Liprostin) Treatment With Lower Limb Angioplasty for Peripheral Arterial Occlusive Disease
Recruitment status was: Recruiting
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Peripheral Vascular Disease | Drug: Liprostin [liposomal Prostaglandin E1] | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized 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 |
| Estimated Enrollment: | 12 |
| Study Start Date: | February 2003 |
| Estimated Study Completion Date: | August 2003 |
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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00053716
| 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 | |
More Information
| 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 |
Keywords provided by Endovasc:
|
Angioplasty & PGE1 Treatment of Peripheral Vascular Disease |
Additional relevant MeSH terms:
|
Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease Arterial Occlusive Diseases Cardiovascular Diseases Atherosclerosis |
Arteriosclerosis Alprostadil Platelet Aggregation Inhibitors Vasodilator Agents Urological Agents |
ClinicalTrials.gov processed this record on June 26, 2017