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

• Status: Unknown status
• Trial end date: 2003-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Endovasc
• Treatments: Alprostadil

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