Prostaglandin E1 (Liprostin) Treatment With Lower Limb Angioplasty for Peripheral Arterial Occlusive Disease
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/2/2016 |
| Start Date: | February 2003 |
| End Date: | August 2003 |
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
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.
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.
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
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
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
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