Thrombectomy Versus Best Medical Management in Large Vessel Occlusion Stroke Patients Presenting Beyond 24 Hours and With Presence of Collateral Flow on CT Angiography: A Multicentre, Open-label, Registry-linked, Randomised Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Confirmation of ICA or MCA-M1 occlusion, as detected by MRA or CTA, with carotid occlusions potentially occurring in either the cervical or intracranial regions, and the possibility of accompanying tandem MCA lesions.

• Demonstration of moderate to good collateral flow, as evidenced by CTA imaging.

• The patient must be aged 18 years or older.

• The baseline NIHSSS score is equal to or greater than 2, and this score remains equal to or greater than 2 immediately prior to randomization.

• Endovascular treatment can be initiated (via femoral puncture) within a window of 24 to 72 hours from the onset of the stroke. The onset of the stroke is defined as the time the patient was last known to be at their neurologic baseline (patients with wake-up strokes are eligible if they meet the aforementioned time constraints).

• There must be no significant pre-stroke disability, as indicated by a pre-baseline modified Rankin Scale score of 0-2.

• The patient must be willing and able to return for the protocol-required follow-up visits.

• The patient or their legally authorized representative must have signed the Informed Consent form.

Locations
Other Locations
China
Tianjin Huanhu Hospital
RECRUITING
Tianjin
Contact Information
Primary
Ming Wei, MD, PhD
drweiming@163.com
13502182903
Backup
Yongbo Xu, MD
yonbur@outlook.com
17361616533
Time Frame
Start Date: 2024-06-25
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 350
Treatments
Experimental: Endovascular thrombectomy
No_intervention: Best Medical Management
Related Therapeutic Areas
Sponsors
Leads: Tianjin Huanhu Hospital

This content was sourced from clinicaltrials.gov