Under construction – not a live service
Sign in

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

Next steps

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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (14)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Complexo Hospitalario Universitario A CoruñaA CoruñaSpainCompleted
Hospital General Universitario Dr. BalmisAlicanteSpainCompleted
Hospital Universitari Germans Trias i PujolBadalonaSpainCompleted
Hospital Universitario de CrucesBarakaldoSpainCompleted
Hospital de la Santa Creu i Sant PauBarcelonaSpainCompleted
Hospital Clinic de BarcelonaBarcelonaSpainCompleted
Hospital Universitario DonostiaDonostiaSpainCompleted
Hospital Universitari de Girona Doctor Josep TruetaGironaSpainCompleted
University Clinical Hospital Virgen De La ArrixacaMurciaSpainCompleted
Hospital Universitario Central De AsturiasOviedoSpainCompleted
University Hospital Son EspasesPalmaSpainCompleted
Hospital Universitario de NavarraPamplonaSpainCompleted
Hospital Universitario Y Politecnico La FeValenciaSpainCompleted
Hospital Clínico Universitario de ValladolidValladolidSpainCompleted

Are you the coordinator? Confirm the details

This page is information, not medical advice. Discuss any trial with your doctor.