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

September 15, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
440

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Arturo Renú, MD,PhD
  • Phone Number: 2118 0034-93 227 54 00
  • Email: arenu@clinic.cat

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 Trías 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Clinic of Barcelona

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fundacion Clinic per a la Recerca Biomédica
Instituto de Salud Carlos III

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 18, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 26, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 14, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHOICE 2
  • 2023 (U.S. NIH Grant/Contract: GRAMMY Museum Foundation)
  • 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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