Intra-Arterial Tenecteplase to Improve the Microvascular Hemodynamics After Mechanical Thrombectomy (NCT06904911) | Clinical Trial Compass
RecruitingPhase 2
Intra-Arterial Tenecteplase to Improve the Microvascular Hemodynamics After Mechanical Thrombectomy
United States20 participantsStarted 2025-12-11
Plain-language summary
This is a prospective, single-arm, open-label study to evaluate the efficacy of intra-arterial tenecteplase in improving microvascular reperfusion following successful large vessel recanalization. Acute ischemic stroke patients with large anterior circulation large vessel occlusion will receive a single weight-based dose of intra-arterial tenecteplase after achieving successful large vessel recanalization (defined as TICI ≥ 2b) via standard of care mechanical thrombectomy. Microvascular flow will be assessed by quantitative angiography before and after the intra-arterial drug administration in order to quantify the impact of targeted thrombolysis on microvascular reperfusion. Reperfusion will be secondarily assessed with 24-hour imaging, final infarct volume will be quantified 72 hours following treatment, and functional outcome will be assessed in the short-term by the NIHSS and in the long-term by the 90-day modified Rankin Scale.
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:
* Patient/legally authorized representative has signed the Informed Consent Form
* At least 18 years of age
* Ability to comply with the study protocol, in the investigator's judgment
* Acute ischemic stroke attributed to anterior circulation large vessel occlusion (of the internal carotid artery or first segment of the middle cerebral artery based on CTA, MRA, or catheter angiogram) being treated with mechanical thrombectomy
* NIHSS ≥ 6 at the initiation of endovascular therapy (arterial puncture)
* Time from stroke onset to IA-TNK administration \< 24 hours. Stroke onset is defined as the time the patient was last known to be at their neurologic baseline
* ASPECTS ≥ 6 on pre-MT CT imaging
* If treated \> 6 hours from stroke onset, CTP imaging must demonstrates favorable mismatch profile (based on RAPID processing: infarct core \<70 mL, mismatch ratio ≥ 1.8 and mismatch volume ≥ 15 mL)
* Qualifying neuroimaging (CT and CTP, if applicable) must be obtained \<120 minutes prior to arterial puncture.
Exclusion Criteria:
* Current participation in another investigational drug or device study
* Known hypersensitivity or allergy to any ingredients of tenecteplase
* Active internal bleeding
* Known bleeding diathesis (Alzheimer's patients taking lecanemab)
* Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with INR \> 1.7
* Use of one of the new oral anticoagulants within the last 48 hours (da…
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
Change in microvascular cerebral circulation time (mCCT)
Timeframe: The change in mCCT will be calculated as mCCT immediately preceding intra-arterial tenecteplase minus the mCCT immediately following intra-arterial tenecteplase