TerminatedPhase 2

Evaluation of MST-188 in Acute Lower Limb Ischemia

Stopped: Program discontinued to persue alternate indications.

United States4 participantsStarted 2014-06

Plain-language 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.

Who can participate

Age range30 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Angiographic assessment of the change in the volume of thrombus (Exploratory endpoint)

Timeframe: Baseline, 8 and 24 hours

Assessment of the change in TcPO2 (Exploratory endpoint)

Timeframe: Baseline, 8, 12, and 24 hours

Number of participants with adverse events

Timeframe: Randomization through 30 days post-treatment

Trial details

NCT IDNCT02093468

SponsorMast Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-12

View on ClinicalTrials.gov More Acute Limb Ischemia trials