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 range

30 Years – 80 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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