Investigation and Study on the Status of Endovascular Therapy in Acute Ischemic Stroke Ischemic Stroke

NCT ID: NCT03909438

Last Updated: 2023-04-13

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

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2025-06-30

Brief Summary

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This study aims to build a database for patients with acute ischemic stroke who receive endovascular therapy and analyze the current situation, effectiveness, safety and cost-effectiveness of endovascular therapy for acute ischemic stroke in China.

Detailed Description

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Study design is a registry, prospective, multicenter study of acute ischemic stroke patients with endovascular treatment. A database will be established including age, gender, smoking history, blood pressure, blood glucose, previous history (such as coronary heart disease, atrial fibrillation, hypertension, diabetes, stroke history, etc.), history of antiplatelet drugs, onset to treatment time, National Institute of Health Stroke Scale (NIHSS) score before treatment.

Indications for endovascular therapy refer to the current guidelines. All patients will receive endovascular therapy, including direct endovascular therapy or intravenous thrombolysis with endovascular therapy. The effectiveness, safety and cost-effectiveness of endovascular therapy for acute ischemic stroke will be analyzed.

This study will enroll up at least 1,000 patients in 70 centers in China. The primary end point are proportion of patients with good prognosis after 90 days and intracranial hemorrhage transformation type after 24 hours.

Conditions

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Stroke Endovascular Therapy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Endovascular Thrombectomy

Endovascular therapy includes direct mechanical thrombectomy or intravenous thrombolysis with mechanical thrombectomy. Endovascular Thrombectomy Device: Trepo trevor Retriever Device: SolitaireTM FR Revascularization Device

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke
2. Age ≥18 years
3. NIHSS ≥ 6
4. ICA or MCA-M1 or MCA-M2 occlusion as evidenced by MRA or 4D-CTA

Exclusion Criteria

1. Large area cerebral infarction of anterior circulation on early CT image (more than 1/3 of cerebral hemisphere)
2. Blood glucose \<2.7mmol/L or \>22.2mmol/L
3. Other serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 90 days
4. Pregnant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fourth Affiliated Hospital, School of Medicine, Zhejiang University

UNKNOWN

Sponsor Role collaborator

Taizhou Hospital

OTHER

Sponsor Role collaborator

Lishui Country People's Hospital

OTHER

Sponsor Role collaborator

The Central Hospital of Lishui City

OTHER

Sponsor Role collaborator

Shaoxing People's Hospital

OTHER

Sponsor Role collaborator

Ganzhou People's Hospital

UNKNOWN

Sponsor Role collaborator

Luoyang Central Hospital

OTHER

Sponsor Role collaborator

Huizhou Municipal Central Hospital

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of Jiaxing University

OTHER

Sponsor Role collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role collaborator

The First People's Hospital of Huzhou

OTHER

Sponsor Role collaborator

Taizhou First People's Hospital

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Min Lou, Ph.D

Role: STUDY_DIRECTOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

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Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Min Lou, Ph.D

Role: CONTACT

13958007213

Facility Contacts

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MIN LOU, Ph.D.

Role: primary

8657187784811

Other Identifiers

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IS-EVT

Identifier Type: -

Identifier Source: org_study_id

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