Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06654375

Thrombectomy Versus Best Medical Management in Large Vessel Occlusion Stroke Patients Presenting Beyond 24 Hours and With Presence of Collateral Flow on CT Angiography

Led by Tianjin Huanhu Hospital · Updated on 2024-10-23

350

Participants Needed

1

Research Sites

183 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to investigate if endovascular treatment (EVT) can effectively treat patients with large vessel occlusion (LVO) who present beyond the typical 24-hour window after symptom onset. The main questions it aims to answer are: * Can EVT improve functional independence at 90 days for patients treated after 24 hours? * What is the safety profile of EVT in this delayed treatment group compared to best medical management (BMM)? Researchers will compare EVT outcomes in patients presenting after 24 hours to those receiving BMM to see if EVT offers significant benefits. Participants will: * Receive either EVT or BMM based on their eligibility. * Undergo CT angiography to assess collateral circulation and to confirm the presence of LVO. * Be followed for 90 days to evaluate functional outcomes and safety measures.

CONDITIONS

Official Title

Thrombectomy Versus Best Medical Management in Large Vessel Occlusion Stroke Patients Presenting Beyond 24 Hours and With Presence of Collateral Flow on CT Angiography

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed occlusion in the internal carotid artery or middle cerebral artery (M1 segment) by MRA or CTA.
  • Moderate to good collateral blood flow shown by CT angiography.
  • Age 18 years or older.
  • National Institutes of Health Stroke Scale score of 2 or higher before randomization.
  • Ability to start endovascular treatment between 24 and 72 hours after stroke onset.
  • No significant disability before stroke (modified Rankin Scale score 0-2).
  • Willing and able to attend follow-up visits.
  • Signed informed consent by patient or legal representative.
Not Eligible

You will not qualify if you...

  • Serious, advanced, or terminal illness with life expectancy under six months.
  • Medical, neurological, or psychiatric conditions interfering with evaluations or participation in another drug/device study.
  • Pregnancy.
  • Contraindications for MRI or CT contrast that prevent required imaging studies.
  • Known allergy to iodine not responsive to pretreatment.
  • Treatment with tPA more than 4.5 hours after last known well time.
  • Known bleeding disorders or recent anticoagulant therapy with high INR.
  • Stroke symptoms in multiple brain areas.
  • Seizures at stroke onset making diagnosis uncertain.
  • Extremely low or high blood glucose levels at baseline.
  • Very low platelet count at baseline.
  • Severe hypertension not treatable with medication.
  • Participation in other investigational studies or registries.
  • Suspected septic embolus, bacterial endocarditis, or cerebral vasculitis.
  • Clot removal attempted within 24 hours of symptom onset.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, China, 300070

Actively Recruiting

Loading map...

Research Team

M

Ming Wei, MD, PhD

CONTACT

Y

Yongbo Xu, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here