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CHemical OptImization of Cerebral Embolectomy in patients with acute stroke treated with mechanical thrombectomy 2 (CHOICE2TRIAL)
EU CTIS ID: 2023-504262-32-01
What this study is testing
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).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility criteria
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.