Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy Pilot Trial (NCT05172934) | Clinical Trial Compass
CompletedPhase 2
Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy Pilot Trial
United States20 participantsStarted 2022-04-11
Plain-language summary
Prospective, single center, non-randomized, pilot study to assess the feasibility of IA TNK following standard of care mechanical thrombectomy (MT) in patients with AIS. Participants will receive IA TNK after achieving mTICI 2b or 2c reperfusion with standard of care MT. Patients enrolled into the study will be followed for 3 months after treatment with IA TNK.
Who can participate
Age range
18 Years – 85 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:
* 1\. Age 18-85
* 2\. Anterior circulation ischemic stroke symptoms with confirmed occlusion (ICA, M1, or M2) on angiogram and mechanical thrombectomy initiated within 24 hours since last known well
* 3\. a. Patients treated less than 6 hours since last known well with ASPECTS \>6. b. Patients treated beyond 6 hours since last known well, CT or MRI perfusion scan showing favorable mismatch profile (Target mismatch profile on CT perfusion or MRI (ischemic core volume is \<70ml, mismatch ratio is \>1.8 and mismatch volume is \>15ml)
* 4\. Post-mechanical thrombectomy with ≤5 device passes and mTICI grade 2b or 2c with persistent occlusion(s) in terminal branches not amenable to MT.
* 5\. Signed informed consent
Exclusion Criteria:
* 1\. Premorbid modified Rankin scale (mRS) score of 4 or greater
* 2\. Presence of any hemorrhage and/or ASPECT score ≤6 on baseline head CT
* 3\. Platelet count \<100,000
* 4\. Known bleeding diathesis
* 5\. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
* 6\. Active anticoagulation treatment with novel oral anticoagulant (NOACs) taken within the last 48 hours, or INR \>1.8
* 7\. Patients requiring active treatment with dual antiplatelet agents (e.g. proximal cervical carotid artery stenting)
* 8\. Pregnant or lactating
* 9\. Previous known allergy to TNK
* 10\. Major surgery in past 30 days
* 11\. Patient is on or requires dialysis
* 12\. History of intracranial hemorrhage or serious head tr…
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
Incidence of Any Intracranial Hemorrhage and Neurologic Worsening
Timeframe: 24 hours (+/- 8 hours) post-treatment with intra-arterial Tenecteplase