A Study of Intra-thrombus Plasmin (Human) In Acute Peripheral Arterial Occlusion (NCT01222117) | Clinical Trial Compass
CompletedPhase 2
A Study of Intra-thrombus Plasmin (Human) In Acute Peripheral Arterial Occlusion
United States, Belgium, Bulgaria174 participantsStarted 2010-12
Plain-language summary
The primary purpose of this Phase 2 study is to optimize Plasmin delivery by comparing different delivery regimens in patients with peripheral arterial occlusion. The study includes a blinded plasminogen activator treatment group and a blinded plasminogen activator placebo group. The study will also assess safety and tolerability of Plasmin at 150 and 250 mg doses.
Who can participate
Age range
18 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:
* Unilateral limb ischemia - Society of Vascular Surgery Categories I and IIa
* Onset of symptoms less than or equal to 14 days
* Thrombosed infrainguinal bypass graft or native artery
* Diagnosis by arteriography of occlusive thrombus in graft or artery
* Ability to embed the infusion catheter into the thrombus
* Women of childbearing potential must use contraception and have a negative pregnancy test
Exclusion Criteria:
* Any medical or social condition that may interfere with study participation
* Women who are pregnant or lactating
* Hemorrhagic stroke history
* Thrombotic or embolic stroke or cerebrovascular events (including transient ischemic attack) within one year
* Intracranial or spinal neurosurgery, or severe intracranial trauma in the last 3 months
* Major surgery, organ biopsy, or major trauma within the past 10 days
* Lumbar puncture or non-compressible arterial puncture in the past 10 days
* Intraocular surgery within the past 10 days
* Active gastrointestinal or organ bleeding
* Uncontrolled arterial hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg)
* Known intracranial neoplasm, aneurysm, or arteriovenous malformation
* Current bleeding diathesis
* Platelet count \<75 x 10e9/L
* Active graft infection
* Occlusion occurred within one month of synthetic graft placement
* Occlusion occurred within 6 months of autologous graft placement
* A sequential composite graft with dual outflows to correct mult…
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
1
The Proportion of Subjects With >50% Thrombolysis
Timeframe: 5 hours (Treatment Groups A, B, C, G, I, M) or 2 hours (Treatment Groups D, H, J)