Evaluation of MST-188 in Acute Lower Limb Ischemia

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of MST-188 in subjects receiving catheter-directed rt-PA for acute lower limb ischemia and to evaluate whether treatment with MST-188 results in more rapid thrombolysis of the occlusion and more rapid tissue perfusion in the effected blood vessel.

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

Details

• Lead Sponsor: Mast Therapeutics, Inc.
• Treatments: Tissue Plasminogen Activator

Criteria

Inclusion Criteria:

• Age ≥30 to <80

• Symptoms consistent with ALI in target lower limb classified as Rutherford Category IIa or IIb

• Subject is hospitalized or in the process of hospitalization for the treatment of ALI

• Angiographic confirmation of thrombotic lower limb arterial occlusion

Exclusion Criteria:

• Prosthetic bypass graft occlusion within 1 month of implantation or autogenous graft occlusion within 6 months of placement

• Treatment with a thrombolytic agent within the last 48 hours

• Subject's laboratory results indicate inadequate organ function

• NYHA Class IV congestive heart failure

• Prior major amputation of the target limb

• Other complications or contraindications for receiving rt-PA, anticoagulants, or contrast media