NCT05659160

Brief Summary

The objective of this study is to create a comprehensive, real-world, multi-center observational registry of consecutive patients admitted to hospitals with acute ischemic stroke (AIS) caused by large vessel occlusions (LVO), who are treated with either endovascular therapy (EVT) or the best available medical management (BMM).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Nov 2021

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

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

Study Progress63%
Nov 2021Dec 2028

Study Start

First participant enrolled

November 1, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

7.2 years

First QC Date

December 13, 2022

Last Update Submit

November 28, 2023

Conditions

Keywords

Acute Ischemic StrokeEndovascular TherapyLarge Vessel Occlusion

Outcome Measures

Primary Outcomes (2)

  • Modified ranking scale (mRS) at 90 days

    A 0-6 scale running from perfect health without symptoms to death.

    90 days

  • Mortality within 90 days

    mortality of any causes.

    90 days

Secondary Outcomes (4)

  • National Institutes of Health Stroke Scale (NIHSS) scores at 90 days

    90 days

  • Occurrence of periprocedural complications

    14 days postoperatively

  • ASPECT (Alberta Stroke Program Early CT score)

    Day 0

  • EuroQol five dimensions questionnaire (EQ-5D)

    1 year

Study Arms (2)

Endovascular therapy

Timely thrombectomy for acute ischemic stroke patients with large vessel occlusion by either stent retriever, thrombus aspiration, others, or combination methods.

Procedure: Endovascular Therapy

Best medical management

Patients enrolled in this group received the best medical management.

Interventions

Endovascular therapy, as an adjunct to standard stroke therapy, may be beneficial for a very select population of patients who present with an acute ischemic stroke and have a proven large, proximal occlusion on imaging. Endovascular therapy includes any one or more of the following: Intra-arterial thrombolytic therapy, aspiration, stent retrieval, or a combination of multiple mechanical devices.

Endovascular therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All acute ischemic stroke patients with large vessel occlusion.

You may qualify if:

  • Patient admitted from Jan. 1st 2018 to Jan. 1st 2028;
  • Age ≥ 18;
  • Ischemic stroke confirmed by head CT or MRI;
  • Large vessel occlusion confirmed by head CTA or MRA: intracranial internal carotid artery (ICA), middle cerebral artery (MCA M1/M2), anterior cerebral artery (ACA A1/A2), basilar artery (BA), vertebral artery (VA), and posterior cerebral artery (PCA P1/P2);
  • Patients receiving either endovascular therapy or best medical treatment;

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

RECRUITING

The Sencond Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, 300211, China

RECRUITING

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, 300222, China

RECRUITING

Beijing University Binhai Hospital

Tianjin, Tianjin Municipality, 300450, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Ming Wei, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

December 13, 2022

First Posted

December 21, 2022

Study Start

November 1, 2021

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

December 1, 2023

Record last verified: 2023-11

Locations