NCT05311605

Brief Summary

The aim of the study was to establish a clinical and advanced imaging database of acute ischemic stroke patients treated with mechanical thrombectomy due to large vessel occlusion of anterior circulation within 24 hours from stroke onset in China, and to investigate the predictors and potential mechanisms of futile recanalization after mechanical thrombectomy.

Trial Health

57
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 5, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

February 23, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

1.6 years

First QC Date

March 28, 2022

Last Update Submit

March 19, 2024

Conditions

StrokeVascular OcclusionEndovascular TreatmentMechanical ThrombectomyPerfusion Imaging

Keywords

ischemic strokevascular occlusionendovascular treatmentmechanical thrombectomyperfusion imaging

Outcome Measures

Primary Outcomes (1)

  • Favorable functional outcome

    proportion of mRS score 0-2 at 3 months. The modified Rankin Scale (mRS) has a minimum value of 0 and maximum value of 6. Higher value indicated worse functional outcome

    3 months from stroke onset

Secondary Outcomes (6)

  • Excellent functional outcome at 90 days

    3 months from stroke onset

  • Ordinal distribution of mRS at 90 days

    3 months from stroke onset

  • EQ-5D score at at 90 days

    3 months from stroke onset

  • Neurological improvement at 24 hours

    24 hours from stroke onset

  • recanalization post-operation

    (Day 0) immediately the surgeon thought the thrombectomy completed and performed a second cerebral angiography .

  • +1 more secondary outcomes

Other Outcomes (3)

  • Infarction volume at 24 hours

    24 hours after thrombectomy completed

  • symptomatic intracerebral hemorrhage at 36 hours

    36 hours after thrombectomy completed

  • Mortality at 90 days

    90 days after thrombectomy completed

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

ischemic stroke patients that received mechanical thrombectomy due to large vessel occlusion of anterior circulation within 24 hours from stroke onset and had perfusion imaging both before and after thrombectomy.

You may qualify if:

  • Older than 18 years;
  • Perfusion imaging completed including CTA+CTP or MRA+PWI+DWI before thrombectomy
  • Large vessel occlusion of cerebral anterior circulation (ICA, MCA-M1 or MCA-M2) confirmed by CTA or MRA, planned to receive or received stenting or aspiration thrombectomy
  • mRS score ≤2 before admission
  • Informed consent obtained for longitudinal enrolled patients, waived of consent for retrospectively included cases

You may not qualify if:

  • Had a history of infective disease, immunity disease, radiotherapy at head or neck, carotid dissection or other carotid disease.
  • Unable to receive CT or MR scan due to heart failure, cardiac pacemaker, metal implants or claustrophobia, etc.
  • Unable to be injected with contrast agent due to allergy, renal dysfunction, etc.
  • Unlikely to adhere to the study protocol or follow-up ( life expectancy ≤ 3 months)
  • Already participated in other drug trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yunyun Xiong

Beijing, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum sample

MeSH Terms

Conditions

StrokeIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Yunyun Xiong, MD, PhD

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunyun Xiong, MD, PhD

CONTACT

00861059975213xiongyunyun@bjtth.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology and Stroke Center

Study Record Dates

First Submitted

March 28, 2022

First Posted

April 5, 2022

Study Start

February 23, 2023

Primary Completion

September 30, 2024

Study Completion

December 31, 2024

Last Updated

March 21, 2024

Record last verified: 2024-03

Locations

CN(1)