Intra-arterial Microplasmin Administration in Patients With Acute Peripheral Arterial Occlusion

• Status: Terminated
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the trial is to evaluate the safety and efficacy of microplasmin administration in patients with acute peripheral arterial occlusion.

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

Details

• Lead Sponsor: ThromboGenics
• Treatments: Fibrinolysin; Plasminogen

Criteria

Inclusion Criteria:

• Patients presenting within 14 days of onset of acute thrombotic or embolic arterial occlusion of a lower extremity (native vessel or bypass graft).

• Complete occlusion of infrarenal vessel or bypass graft, as determined by angiography.

• Lower extremity ischemia graded as SVS/ISCS (Society of Vascular Surgery/ International Society for Cardiovascular Surgery) class I or II (a or b).

• Negative urine pregnancy test (pregnancy test only required for females of child-bearing potential not using an accepted method of contraception).

Exclusion Criteria:

• Profound ischemia with permanent motor paresis or sensory loss (or ischemic process deemed irreversible, i.e. class III).

• Occlusion not penetrable by the infusion guide wire.

• Known or suspected allergy to contrast agents or heparin sodium.

• Active bleeding or known hemorrhagic diathesis.

• Stroke in the previous 6 months or transient ischemic attack in the previous 2 months.