Evaluation of MST-188 in Acute Lower Limb Ischemia

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02093468

Enrollment

Registered

2014-03-21

Start date

2014-06-30

Completion date

Unknown

Last updated

2015-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Limb Ischemia

Keywords

Acute limb ischemia, ALI, Acute lower extremity arterial occlusion

Brief 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.

Interventions

DRUGMST-188

DRUGSaline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Angiographic assessment of the change in the volume of thrombus (Exploratory endpoint)	Baseline, 8 and 24 hours
Assessment of the change in TcPO2 (Exploratory endpoint)	Baseline, 8, 12, and 24 hours
Number of participants with adverse events	Randomization through 30 days post-treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026