CHemical OptImization of Cerebral Embolectomy in patients with acute stroke treated with mechanical thrombectomy 2 (CHOICE2TRIAL)
- Conditions
- Cerebral Embolectomy in patients with acute strokeTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2023-504262-32-01
- Lead Sponsor
- Foundation Clinic For Biomedical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 440
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.
NIHSS score on admission >25, Renal Failure as defined by a serum creatinine > 3.0 mg/dl (or 265.2 µmol/l) or glomerular Filtration Rate [GFR] < 30, Subject who requires hemodialysis or peritoneal dialysis, or who have a contraindication to an angiogram for whatever reason, Any hemorrhage on CT/MRI, Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal, Suspicion of aortic dissection, 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, SBP >185 mmHg or DBP >110 mmHg refractory to treatment, Serious, advanced, terminal illness with anticipated life expectancy < 6 months, Pre-existing neurological or psychiatric disease that would confound evaluation, Contraindication to IV t-PA as per local national guidelines (except time to therapy), Presumed vasculitis or septic embolization, Unlikely to be available for 90-day follow-up (i.e., no fixed home address, visitor from overseas), Use of carotid artery stents during the endovascular procedure requiring dual antiplatelet therapy during the first 24h, 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, Current participation in another investigation drug or device treatment study, Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency, Known coagulopathy, or INR > 1.7, Platelets < 50,000
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method