The purpose of this phase I trial is to evaluate the safety and feasibility of robot-assisted stereotactic minimally invasive hematoma aspiration, followed when eligible by intrahematoma tenecteplase administration, in patients who develop symptomatic supratentorial PH2 hemorrhagic transformation after reperfusion therapy for acute ischemic stroke. The main study questions are whether this strategy is associated with an acceptable early rebleeding risk and whether it can achieve clinically meaningful hematoma reduction with accurate catheter placement and relief of hematoma-related mass effect.
Prestroke modified Rankin Scale score of 0 to 2.
Acute ischemic stroke treated with reperfusion therapy (standard-dose intravenous thrombolysis using alteplase or tenecteplase, or mechanical thrombectomy or any other endovascular reperfusion procedure for the index stroke).
CT-confirmed symptomatic PH2 hemorrhagic transformation according to ECASS criteria in a supratentorial deep or lobar location, with hematoma-related mass effect and/or midline shift.
Hematoma volume 20 to 80 mL measured by ABC/2 method.
HI1, HI2, or PH1 hemorrhagic transformation without clinically relevant mass effect.
Infratentorial hemorrhage, including brainstem or cerebellar hemorrhage.
Large malignant hemispheric infarction in which the dominant cause of mass effect is ischemic edema rather than hematoma, or clear need for decompressive craniectomy as first-line treatment.
Hemorrhage primarily attributable to aneurysm, arteriovenous malformation, dural arteriovenous fistula, moyamoya disease, tumor, trauma, or another structural lesion; or hemorrhage caused predominantly by a procedural vascular injury unrelated to thrombolysis-associated hemorrhagic transformation.