Study of Alfimeprase's Ability to Dissolve Blood Clots in the Leg and Help Prevent the Need for Surgery

• Status: Terminated
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to directly compare the safety and efficacy of intra-thrombus alfimeprase 0.3 mg/kg with placebo in acute peripheral arterial occlusion (PAO) as measured by a 30 day open vascular free surgery rate.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ARCA Biopharma, Inc.

Criteria

Inclusion Criteria:

• Age 18 or older

• Arteriographically confirmed acute PAO of the lower extremity with onset of symptoms within 14 days prior to randomization

• Acute index limb ischemia classified as SVS/ISCVS Class I or IIa caused by occlusion of a native artery and/or bypass graft (vein or prosthetic). Only Class I subjects with abrupt onset of ischemic rest pain or abrupt onset/progression of lifestyle-limiting claudication are eligible

• Acute PAO with a need for urgent surgical intervention to restore arterial blood flow in the event of unsuccessful thrombolytic therapy

• Available for follow-up assessments

Exclusion Criteria:

• Contraindication to systemic anticoagulation

• History of endovascular procedure or open vascular surgery on the index limb within the past 30 days

• History of significant acute or chronic kidney disease that would preclude contrast angiography

• Known allergy to contrast agents

• History of heparin induced thrombocytopenia

• Participation in any study of an investigational device, medication, biologic, or other agent within 30 days prior to randomization

• Any thrombolytic therapy within 5 days prior to randomization

• Past participation in any alfimeprase trial

• Pregnant, lactating, or actively menstruating women or women of childbearing potential who are not using adequate contraceptive precautions

• Investigator inability to advance guidewire through index occlusion

• Any other subject feature that in the opinion of the investigator should preclude study participation