Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT05499832
Eligibility Criteria:
Inclusion Criteria
* Informed consent
* Age ≥18 years
* Clinical signs consistent with an acute ischemic stroke
* Patient had an initial vessel occlusion in the anterior or posterior circulation defined as intracranial ICA, M1, M2, M3, A1, A2, P1 or P2
* Patient has undergone endovascular stroke treatment
* Onset to randomization no later than \< 705 minutes (11h 45min) after symptom-onset/last-seen well.
* Incomplete reperfusion defined as any of the following:
1. For ICA/M1: TICI2b/2c (50-99%) reperfusion after endovascular treatment without mechanically amendable target-occlusion (as per definition by the interventionalist).
2. For A1/A2, P1/P2, M2/M3: TICI2a/2b/2c (1-99%) reperfusion after endovascular treatment without mechanically amendable target-occlusion (as per definition by the interventionalist).
3. Any emboli to new territory without mechanically amendable target-occlusion (as per definition by the interventionalist).
* Signs of early ischemic changes of non-contrast CT Alberta Stroke Program Early CT Score (ASPECTS) ≥5 (for DWI-ASPECTS ≥ 4, for DWI-ASECTS: a region must have diffusion abnormality in 20% or more of its volume to be considered DWI-ASPECTS positive)
Exclusion Criteria
* Acute intracranial hemorrhage
* Contraindication to MRI (e.g. pacemaker)
* Any severe bleeding within the past 6 months, which would prevent administration of intravenous thrombolysis in clinical routine Major surgery in the past 2 months with severe risk of bleeding, which would prevent administration of intravenous thrombolysis in clinical routine
* Intake of Vitamin K antagonists with INR \>1.7
* Platelets \< 50,000
* Non-controlled hypertension (defined as SBP \>185 mmHg or DBP \>110 mmHg refractory to treatment)
* Active dyspeptic ulcer
* Known arterial aneurysm
* Known neoplasms with risk of bleeding
* Severe liver fibrosis or portal hypertension
* Acute pericarditis
* Acute endocarditis
* Acute pancreatitis
* Known allergy to TNK or Gentamicin or other additives/auxiliaries (Polysorbatum 20, L-Argininum, Acidum phosphoricum)
* Known Renal failure either as defined by a serum creatinine \> 3.0 mg/dl (or 265.2 μmol/l) or glomerular Filtration Rate \[GFR\] \< 30 or as subject who required hemodialysis/peritoneal dialysis
* Radiological confirmed evidence of mass effect or intracranial tumor (except small meningioma)
* Radiological confirmed evidence of cerebral vasculitis
* Calcified thrombi
* Pregnancy or lactating women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05499832
Study Brief:
Protocol Section:
NCT05499832