CHemical OptImization of Cerebral Embolectomy in patients with acute stroke treated with mechanical thrombectomy 2 (CHOICE2TRIAL)

Trial details

Who runs it

Foundation Clinic For Biomedical Research

Trial code

EU 2023-504262-32-01

Record updated

2025. február 10.

Original description

The study objective is to evaluate whether rt-PA is efficient as an add-on to mechanical thrombectomy in patients with acute ischemic stroke and recanalization with complete or near-complete reperfusion of a proximal vessel occlusion on cerebral angiogram (corresponding to mTICI score 2b/3).Read full original descriptionShow less

The study objective is to evaluate whether rt-PA is efficient as an add-on to mechanical thrombectomy in patients with acute ischemic stroke and recanalization with complete or near-complete reperfusion of a proximal vessel occlusion on cerebral angiogram (corresponding to mTICI score 2b/3).

Inclusion: Patients with symptomatic large vessel occlusion (LVO) in the anterior circulation (TICA, ACA or MCA) treated with MT resulting in a mTICI angiographic score 2b/3 at end of the procedure; Estimated delay to onset of rescue IA rt-PA administration <24 hours from symptom onset, defined as the point in time the patient was last seen well; No significant pre-stroke functional disability (modified Rankin scale 0-1, or mRS >1 that according to the investigator is not related to neurological disease (i.e. amputation, blindness)); Age ≥18; ASPECTS ≥6 on non-contrast CT (NCCT) scan if symptoms lasting <4.5 hours of last seen well. In patients with >4.5h of last seen well, a CT-perfusion (Flow maps) or MRI-perfusion should be considered, especially if >9h have elapsed, or in seriously ill patients (i.e., NIHSS>17). If a perfusion study is not available before MT, NCCT can still be used if the ASPECTS is ≥ 6; Informed consent obtained from patient or acceptable patient surrogate.

Exclusion: Contraindication to IV t‐PA as per local national guidelines (except time to therapy); Use of carotid artery stents during the endovascular procedure requiring dual antiplatelet therapy during the first 24h; Current participation in another investigation drug or device treatment study; Any hemorrhage on CT/MRI; Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal; Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol; History of life-threatening allergy (more than rash) to contrast medium; Serious, advanced, terminal illness with anticipated life expectancy < 6 months; Pre-existing neurological or psychiatric disease that would confound evaluation; Renal Failure as defined by a serum creatinine > 3.0 mg/dl (or 265.2 μmol/l) or glomerular Filtration Rate [GFR] < 30; Known coagulopathy, or INR > 1.7; Platelets < 50,000; NIHSS score on admission >25; Subject who requires hemodialysis or peritoneal dialysis, or who have a contraindication to an angiogram for whatever reason; Suspicion of aortic dissection; SBP >185 mmHg or DBP >110 mmHg refractory to treatment; Presumed vasculitis or septic embolization; Unlikely to be available for 90-day follow-up (i.e., no fixed home address, visitor from overseas); Need of more than 3 passes (per vessel) or more than a total of 5 passes (in more than one vessel) to complete the endovascular procedure; Female who is pregnant or lactating or has a positive pregnancy test at time of admission; Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency.

EU CTIS 2023-504262-32-01