NCT03887143

Brief Summary

The purpose of this study is to evaluate recanalization treatments use, safety and efficacy at the acute phase of arterial ischemic stroke in pediatric patients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

April 4, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2021

Completed
Last Updated

November 20, 2025

Status Verified

October 1, 2025

Enrollment Period

2.2 years

First QC Date

January 10, 2019

Last Update Submit

November 17, 2025

Conditions

Arterial Ischemic Stroke

Keywords

Ischemic strokechildrenrecanalization treatmentthrombolysisthrombectomy

Outcome Measures

Primary Outcomes (3)

  • Acute management of stroke:

    Median time from symptom onset to Imaging (minutes)

    1 day

  • Acute management of stroke:

    Median time from symptom onset to beginning of recanalization treatment (minutes)

    1 day

  • Acute management of stroke:

    Median door-to-needle delay (minutes)

    1 day

Secondary Outcomes (10)

  • Treatment-emergent adverse events:

    7 days

  • Treatment-emergent adverse events:

    7 days

  • Treatment-emergent adverse events:

    7 days

  • factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis

    12 months

  • factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis

    12 months

  • +5 more secondary outcomes

Study Arms (1)

Arterial ischemic stroke in patients less than 18 years old

Patients \< 18 years old * Suspected or confirmed cerebral infarction * With recanalization treatment in the acute phase: intra-venous thrombolysis +/- intra-arterial thrombolysis +/- thrombectomy * Patients treated between January 2015, 1st and May 2018, 31st

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients aged less than 18 yo with arterial ischemic stroke and recanalization treatment at the acute phase, treated in France during the study period. Sample recruited from pediatric and adult databases of child neurology, stroke, and interventional radiology units

You may qualify if:

  • Patients under 18 years old
  • Suspected or confirmed cerebral infarction
  • With recanalization treatment in the acute phase : intravenous thrombolysis +/- intra-arterial thrombolysis +/- thrombectomy
  • Patients treated between the January 2015, 1st and the May 2018, 31st
  • Collection of non-opposition from legal representatives

You may not qualify if:

  • \- Refusal of the patient's legal representative to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necker- Enfants Malades Hospital

Paris, Paris, 75015, France

Location

Related Publications (2)

  • Kossorotoff M, Kerleroux B, Boulouis G, Husson B, Tran Dong K, Eugene F, Damaj L, Ozanne A, Bellesme C, Rolland A, Bourcier R, Triquenot-Bagan A, Marnat G, Neau JP, Joriot S, Perez A, Guillen M, Perivier M, Audic F, Hak JF, Denier C, Naggara O; KidClot Group. Recanalization Treatments for Pediatric Acute Ischemic Stroke in France. JAMA Netw Open. 2022 Sep 1;5(9):e2231343. doi: 10.1001/jamanetworkopen.2022.31343.

    PMID: 36107427RESULT

  • Tudorache R, Kossorotoff M, Kerleroux B, Denier C, Naggara O, Boulouis G; KID-CLOT Group. Determinants of Timely Access to Recanalization Treatments and Outcomes in Pediatric Ischemic Stroke. Stroke. 2024 Nov;55(11):2716-2719. doi: 10.1161/STROKEAHA.124.046417. Epub 2024 Oct 1.

    PMID: 39351662DERIVED

Related Links

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Manoelle Kossorotoff, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2019

First Posted

March 22, 2019

Study Start

April 4, 2019

Primary Completion

May 29, 2021

Study Completion

May 29, 2021

Last Updated

November 20, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)