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

NCT03909438 | Unknown DMC

• 1 other identifier: IS-EVT
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Endovascular Therapy

Outcome Measures

Primary Outcomes (2)

• Good Functional Independence

  This outcome will look at the proportion of patients with mRS 0-2 at day 90.

  90 days

• Hemorrhage transformation

  hemorrhage transformation at 24-hour after reperfusion therapy: * Hemorrhagic infarction 1 (HI1) was defined as small petechiae along the margins of the infarct; * Hemorrhagic infarction 2 (HI2) as confluent petechiae within the infarcted area but no space-occupying effect; * Parenchymal hemorrhage (PH1) as blood clots in 30% or less of the infarcted area with some slight space- occupying effect; and * Parenchymal hemorrhage (PH2) as blood clots in more than 30% of the infarcted area with substantial space- occupying effect. * Symptomatic intracranial hemorrhage was defined as blood at any site in the brain on the CT scan.

  24-hour

Secondary Outcomes (2)

• Poor outcome

  90 days

• The incidence of recurrent stroke or other vascular events

  90 days

Interventions

Endovascular Thrombectomy PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients will receive endovascular therapy, including direct endovascular therapy or intravenous thrombolysis with endovascular therapy.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Fourth Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• Taizhou Hospital: collaborator
• Lishui Country People's Hospital: collaborator
• The Central Hospital of Lishui City: collaborator
• Shaoxing People's Hospital: collaborator
• Ganzhou People's Hospital: collaborator
• Luoyang Central Hospital: collaborator
• Huizhou Municipal Central Hospital: collaborator
• The Second Affiliated Hospital of Jiaxing University: collaborator
• Shanghai Zhongshan Hospital: collaborator
• The First People's Hospital of Huzhou: collaborator
• Taizhou First People's Hospital: collaborator

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Min Lou, Ph.D

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY DIRECTOR

Central Study Contacts

Min Lou, Ph.D

CONTACT

13958007213; loumingxc@vip.sina.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 10, 2019
• Study Start: September 1, 2018
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2025
• Last Updated: April 13, 2023

Record last verified: 2023-04

Locations

CN (1)