CHemical OptImization of Cerebral Embolectomy 2 (CHOICE 2). (CHOICE2)

September 8, 2025 updated by: Angel Chamorro, M.D., Ph.D., Hospital Clinic of Barcelona

CHemical OptImization of Cerebral Embolectomy in Patients With Acute Stroke Treated With Mechanical Thrombectomy 2 (CHOICE 2 TRIAL)

Multi-center, randomized, parallel-group, superiority study to compare the efficacy of adjunct intra-arterial rt-PA versus not adjunct intra-arterial rt-PA in the improvement of the efficacy of mechanical thrombectomy in patients with large vessel occlusion acute ischemic stroke.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The study objective is to validate whether the administration of intra-arterial rt-PA is efficient as an add-on to mechanical thrombectomy in patients with acute ischemic stroke and complete or near-complete recanalization of a proximal vessel occlusion and successful brain reperfusion on cerebral angiogram (corresponding to modified treatment in cerebral infarct (mTICI) score 2b/3). Patients with symptomatic large vessel occlusion (LVO) in the anterior circulation treated with MT resulting in a mTICI score 2b/3 on cerebral angiography will be enrolled in the angiosuite by interventionalists or neurologists once a mTICI 2b/3 is confirmed on cerebral angiography. Each included patient will be followed up to 90 days from the stroke. The primary outcome is the proportion of patients with microvascular hypoperfusion on CT Perfusion at 36±24h. The key secondary outcome is the proportion of patients with a mRS 0 to 1 at 90 days

Study Type

Interventional

Enrollment (Estimated)

440

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Spain
      • A Coruña, Spain, Spain
        • Hospital Universitario de A Coruña
      • Alicante, Spain, Spain
        • Hospital Universitario Dr. Balmis
      • Badalona, Spain, Spain
        • Hospital Germans Trias I Pujol
      • Barcelona, Spain, Spain, 08014
        • Hospital Clinic Barcelona
      • Barcelona, Spain, Spain
        • Hospital De La Santa Creu I Sant Pau
      • Bilbao, Spain, Spain
        • Hospital Universitario de Cruces
      • Girona, Spain, Spain
        • Hospital Josep Trueta
      • Murcia, Spain, Spain
        • Hospital Universitario Virgen de la Arrixaca
      • Oviedo, Spain, Spain
        • Hospital Universitario Central de Asturias
      • Palma de Mallorca, Spain, Spain
        • Hospital Universitario Son Espases
      • Pamplona, Spain, Spain
        • Hospital Universitario de Navarra
      • San Sebastián, Spain, Spain
        • Hospital Universitario de Donostia
      • Valencia, Spain, Spain
        • Hospital Univesitario y Politénico La Fe
      • Valladolid, Spain, Spain
        • Hospital Universitario de Valladolid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with symptomatic large vessel occlusion (LVO) in the anterior circulation (ICA, ACA or MCA) treated with MT resulting in a mTICI score 2b/3 at end of the procedure. Patients with a mTICI score 2b/3 on the diagnostic cerebral angiography before the onset of MT are also eligible for the study.
  • Estimated delay to onset of rescue intraarterial 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 instead of NCCT, especially if >9h have elapsed, or in seriously ill patients (i.e., NIHSS>17). Nonetheless, if a perfusion study is not available, NCCT can still be used as long as it is confirmed without a doubt that the ASPECTS is > 6.
  • Informed consent, obtained from patient or acceptable patient surrogate, or Differed Informed Consent (DIC) to avoid any delay in the initiation of the mechanical thrombectomy and the i.a thrombolysis. The DIC will be signed by the patient or acceptable patient surrogate at any time after the tPA treatment is started.

Exclusion Criteria:

  • NIHSS score on admission >25
  • 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
  • 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, INR > 1.7
  • Platelets < 50,000
  • 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
  • Presumed vasculitis or septic embolization
  • Unlikely to be available for 90-day follow-up (i.e., no fixed home address, visitor from overseas)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intraarterial alteplase
All the patients will be given a 15 minutes IA infusion of alteplase (Actylise®) at a drug concentration of 1.0 mg/ml. At 15 minutes of IA treatment onset, the infusion will be stopped and the angiographic score assessed. Study drug will be prepared according to the following steps: 1/ Dilute 2 vials of 10 mgs (rt-PA) in 20 cc of sterile water for injection (SWI), to attain a 20 ml solution at a concentration of 1mg/ml; 2. Calculate the volume of cc of infusion and therefore the total dose as per the formula: (Patient's weight in Kgs multiplied by 0.225). A patient of 89 Kgs or more will receive 20.0 cc of infusion for 15 min, totaling a dose of 20.0 mg of rt-PA.
Drug: Intraarterial alteplase
See arm/group descriptions.
Other Names:
  • Intraarterial recombinant tissue plasminogen activator (rt-PA)
No Intervention: No intervention
Patients allocated to this arm will receive a similar care to patients allocated to IA alteplase except the thrombolytic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Rankin Scale at day 90
Time Frame: 90 days post treatment
Proportion of patients with Modified Rankin Scale 0 or 1 at day 90 +/- 15d
90 days post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infarct Expansion Ratio (IER): Final infarct to initial ischemic tissue volumes on brain CTP
Time Frame: 36±24hours post treatment
Infarct Expansion Ratio (IER): Final infarct to initial ischemic tissue volumes on brain CTP at 36±24hours post MT.
36±24hours post treatment
Barthel Scale score
Time Frame: day 90 post treatment
Barthel Scale score of 95 to 100, (min value 0, max value 100, higher score better outcome)
day 90 post treatment
EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D-3L)
Time Frame: day 90 post treatment
Quality of life measured with the EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D-3L) The score has five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.
day 90 post treatment
Shift analysis of the modified Rankin Scale (mRS)
Time Frame: day 90 post treatment
Shift analysis of the modified Rankin Scale (mRS), at day 90 (min value 0, max value 6, higher score worse outcome)
day 90 post treatment
Microvascular hypoperfusion on follow-up brain CTP
Time Frame: 36±24hours post treatment
Proportion of patients with abnormal microvascular hypoperfusion on CT Perfusion
36±24hours post treatment
Volume of hypoperfusion on brain CTP
Time Frame: at 36h±24h post treatment
Volume of hypoperfusion on brain CTP
at 36h±24h post treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
SAFETY OUTCOME: Mortality at 90 days
Time Frame: Day 90
Mortality at 90 days
Day 90
SAFETY OUTCOME: symptomatic intracerebral hemorrahge (sICH ) rate at 24 hours.
Time Frame: 24hours post MT
Symptomatic ICH will be classified as per the European Cooperative Acute Stroke Study (ECASS) 3 criteria
24hours post MT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Collaborators

Fundacion Clinic per a la Recerca Biomédica
Instituto de Salud Carlos III

Investigators

  • Principal Investigator: Juan F Arenillas, MD, Hospital Universitario de Valladolid
  • Principal Investigator: María del Mar Freijo, MD, Hospital Universitario de Cruces
  • Principal Investigator: Pedro Vega, MD, Hospital Universitario Central de Asturias
  • Study Chair: Angel Chamorro, MD, PhD, Comprehensive Stroke Center, Hospital Clinic Barcelona
  • Principal Investigator: Arturo Renú, MD, PhD, Comprehensive Stroke Center, Hospital Clinic Barcelona
  • Principal Investigator: Patricia de la Riva, MD, Hospital Donostia
  • Principal Investigator: M Dolores Fernándes, MD, Hospital Universitario de A Coruña
  • Principal Investigator: Lluis Morales, MD, Hospital Universitario La Fe de Valencia
  • Principal Investigator: Laura Dorado, MD, Hospital Germans Trias i Pujol de Badalona
  • Principal Investigator: Mikel Terceño, MD, Hospital Universitario Dr. Josep Trueta de Girona
  • Principal Investigator: Ana Morales, MD, Hospital Universitario Virgen de Arrixaca Murcia
  • Principal Investigator: Maria Herrera, MD, Hospital of Navarra
  • Principal Investigator: Raquel Delgado, MD, Hospital Universitario Son Espases Mallorca
  • Principal Investigator: Nicolás López, MD, Hospital Universitario Dr. Balmis Alicante
  • Principal Investigator: Pol Camps, MD, Hospital Universitario de la Santa Creu i Sant Pau Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2023

Primary Completion (Actual)

August 26, 2025

Study Completion (Estimated)

November 14, 2025

Study Registration Dates

First Submitted

March 9, 2023

First Submitted That Met QC Criteria

March 21, 2023

First Posted (Actual)

April 4, 2023

Study Record Updates

Last Update Posted (Estimated)

September 15, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHOICE 2
  • 2023-504262-32 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual participant data on outcome measures will be published along with the main results of the trial.

IPD Sharing Time Frame

The data will become available after publication of main study results.

IPD Sharing Access Criteria

The IPD will be available from the Sponsor of the trial on reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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