2023-504262-32-01CompletedPhase 3
CHemical OptImization of Cerebral Embolectomy in patients with acute stroke treated with mechanical thrombectomy 2 (CHOICE2TRIAL)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 10 Feb 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 440 (actual)
- First submitted
- 16 Aug 2023
- Start date
- 16 Nov 2023
- Lead sponsor
- Foundation Clinic For Biomedical Research
- Diseases
- Stroke
- EU CT number
- 2023-504262-32-01
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 440
- 14 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- 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
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Complexo Hospitalario Universitario A Coruña | A Coruña | Spain | Completed |
| Hospital General Universitario Dr. Balmis | Alicante | Spain | Completed |
| Hospital Universitari Germans Trias i Pujol | Badalona | Spain | Completed |
| Hospital Universitario de Cruces | Barakaldo | Spain | Completed |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | Completed |
| Hospital Clinic de Barcelona | Barcelona | Spain | Completed |
| Hospital Universitario Donostia | Donostia | Spain | Completed |
| Hospital Universitari de Girona Doctor Josep Trueta | Girona | Spain | Completed |
| University Clinical Hospital Virgen De La Arrixaca | Murcia | Spain | Completed |
| Hospital Universitario Central De Asturias | Oviedo | Spain | Completed |
| University Hospital Son Espases | Palma | Spain | Completed |
| Hospital Universitario de Navarra | Pamplona | Spain | Completed |
| Hospital Universitario Y Politecnico La Fe | Valencia | Spain | Completed |
| Hospital Clínico Universitario de Valladolid | Valladolid | Spain | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.