REperfusion Therapy for Acute Ischemic STrOke Due to Large aRtEry Occlusion

NCT ID: NCT05311605

Last Updated: 2024-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-23

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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The time-window of mechanical thrombectomy for ischemic stroke has extended from 4.5 hours to 24 hours based on the results of the DAWN and DEFUSE 3 trials. However, evidence on the effectiveness and safety of mechanical thrombectomy within 24 hours in the real-world is insufficient.

This is a multi-center, prospective, registry cohort study that acute ischemic stroke patients treated with mechanical thrombectomy due to large vessel occlusion of anterior circulation within 24 hours from stroke onset in China. A retrospective dataset was also build in these stroke centers for analysis. A total of 1600 patients with advanced imaging data were anticipated to be enrolled.

Conditions

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Stroke Vascular Occlusion Endovascular Treatment Mechanical Thrombectomy Perfusion Imaging

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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
* Time intervals ≤ 24 hours from stroke onset to groin puncture.(fulfilled the inclusion of DAWN or DEFUSE 3 trial if the time intervals from stroke onset to groin puncture was ≥6 hours)
* mRS score ≤2 before admission
* Informed consent obtained for longitudinal enrolled patients, waived of consent for retrospectively included cases

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Natural Science Foundation of China

OTHER_GOV

Sponsor Role collaborator

Beijing Municipal Science & Technology Commission

OTHER

Sponsor Role collaborator

Beijing Municipal Administration of Hospitals

OTHER_GOV

Sponsor Role collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yunyun Xiong

Professor of Neurology and Stroke Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yunyun Xiong, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

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Yunyun Xiong

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yunyun Xiong, MD, PhD

Role: CONTACT

00861059975213

Facility Contacts

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Yunyun Xiong

Role: primary

Other Identifiers

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KY-2022-029-01

Identifier Type: -

Identifier Source: org_study_id

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