NCT05885178

Brief Summary

The aim of this study is to establish an academic, real-world, single-center, observational registry of consecutive patients hospitalized with acute ischemic stroke (AIS) due to large vessel occlusions (LVO), treated with either endovascular therapy (EVT) or best medical management (BMM).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

3.8 years

First QC Date

May 23, 2023

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 (3)

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

    90 days

  • Occurrence of periprocedural complications

    14 days postoperatively

  • ASPECT score (Alberta Stroke Program Early CT score)

    Day 0

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.

Procedure: Endovascular Therapy

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.

Best medical managementEndovascular therapy

Eligibility Criteria

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

Patients with acute ischemic stroke due to large vessel occlusion.

You may qualify if:

  • Patient admitted from Jan. 1st, 2018 to June. 1st, 2021;
  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, 300222, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

May 23, 2023

First Posted

June 1, 2023

Study Start

January 1, 2018

Primary Completion

November 1, 2021

Study Completion

January 1, 2025

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations