Reperfusion Completion Via Local Arterial Infusion of Tenecteplase After Incomplete Mechanical Thrombectomy
Starting soon · Phase 3 · Has a placebo group
Conditions studied: Stroke
In brief
To evaluate the efficacy and safety of intra-arterial TNK bridging therapy following incomplete recanalization (2b ≤ eTICI \< 3) after mechanical thrombectomy for acute anterior circulation large vessel occlusion.
Key facts
- Study ID
- NCT07471282
- Run by
- Chuansheng Zhao
- People needed
- 344
- Starts
- 2026-03-01
- Expected to finish
- 2029-03-31
- Last updated by the study team
- 2026-03-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years;
- Time from symptom onset or last known well to randomization within 24 hours;
- Clinical diagnosis of acute ischemic stroke caused by acute occlusion of the intracranial anterior circulation large vessels confirmed by CTA/MRA/DSA, including occlusion of the intracranial segment of the internal carotid artery, the M1 or M2 segments of the middle cerebral artery, with or without concomitant occlusion of the ipsilateral extracranial segment of the internal carotid artery;
- NIHSS score ≥ 6, and meeting the current guidelines for mechanical thrombectomy;
- Anterior circulation large vessel stroke due to occlusion of the intracranial ICA, MCA M1, or M2 segments;
- Pre-stroke mRS score ≤ 1;
- ASPECTS score ≥ 6;
- Post-mechanical thrombectomy status with 2b ≤ eTICI < 3, and the operator has decided not to attempt further mechanical recanalization of the occluded vessel;
- No more than 3 passes with the thrombectomy device;
- Signed informed consent obtained from the patient or their legal guardian.
You may not qualify if…
- Contraindications to intravenous thrombolysis (excluding time-based criteria);
- DSA post-thrombectomy indicating dissection of the occluded artery, or intra-procedural flat-panel CT suggesting local hemorrhage or significant contrast extravasation;
- Baseline NIHSS score not obtained;
- Severe allergy or absolute contraindication to iodinated contrast media;
- Systolic blood pressure ≥ 185 mmHg or diastolic blood pressure ≥ 110 mmHg, refractory to antihypertensive medication;
- Blood glucose < 50 mg/dL (2.8 mmol/L) or > 400 mg/dL (22.2 mmol/L);
- Platelet count < 50 × 10⁹/L, or APTT > 40 s, or PT > 15 s;
- Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; or current use of oral anticoagulants with INR > 1.7;
- Severe renal failure, defined as serum creatinine > 3.0 mg/dL (or 265.2 μmol/L) or glomerular filtration rate [GFR] < 30 mL/min, or requiring hemodialysis or peritoneal dialysis;
- Patient unlikely to complete the 90-day follow-up (e.g., no fixed address, palliative care patient, etc.);
- Suspected vasculitis or septic embolism;
- Suspected aortic dissection;
- Pre-existing neurological or psychiatric disease that would interfere with the assessment of outcomes;
- Pregnancy or lactation;
- Current participation in another clinical trial that could interfere with this study;
- Any other condition deemed by the investigator to make the patient unsuitable for participation or to pose a significant risk to the patient.
Where it is running
- The First Affiliated Hospital of China Medical University — Shenyang, Liaoning, China
Full record on ClinicalTrials.gov
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