Evaluation of MST-188 in Acute Lower Limb Ischemia

Status:	Terminated
Conditions:	Peripheral Vascular Disease
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	30 - 80
Updated:	4/21/2016
Start Date:	June 2014

Evaluation of MST-188 in Acute Lower Limb Ischemia: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial Evaluating the Safety and Efficacy of MST-188 in Subjects With Acute Lower Limb Ischemia Receiving Catheter-Directed Recombinant Tissue Plasminogen Activator

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.

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

We found this trial at

sites

Research Center

15310 Amberly Drive
Tampa, Florida 33606

from

Tampa, FL