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RECRUITING
NCT05735301
NA

Patient Selection Using MR With Non-Perfusion Imaging for Endovascular Treatment Within 6 to 24 Hours

Sponsor: Tianjin Huanhu Hospital

View on ClinicalTrials.gov

Summary

We will conduct a multicenter, prospective, randomized, open-label, blinded endpoint trial with a non-inferiority design in patients who present 6 to 24 hours after symptom onset with LVO. Patients who meet eligibility criteria will be randomly assigned to the Non-perfusion or Perfusion group with a 1:1 ratio. In the Non-perfusion group, patients with penumbra-core mismatch (defined as the FLAIR Vascular Hyperintensity (FVH) extending beyond the boundary of the DWI cortical lesions) will receive EVT. In the Perfusion group, patients with perfusion mismatch (defined as regional cerebral blood flow (\<30%) \< 70 ml with mismatch ratio ≥ 1.8 and mismatch volume ≥ 15 ml) will receive EVT. Patients in both groups will receive guideline-based medical treatment. If patients in both groups do not meet the criteria for EVT, only guideline-based medical treatment will be administered.

Official title: Patient Selection Based on Penumbra-core Mismatch Using MR With Non-Perfusion Imaging for Endovascular Treatment Within 6 to 24 Hours: Rationale and Trial Design

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

352

Start Date

2019-01-01

Completion Date

2024-09

Last Updated

2024-06-24

Healthy Volunteers

No

Interventions

PROCEDURE

Endovascular

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.Remedial measures after failed thrombectomy are permitted by pharmacologic arterial thrombolysis or intravenous infusion of antiplatelet drugs, such as tirofiban or rt-PA

DRUG

Drug

best drug conservative therapy could be uesd in patients who with no indication of surgery

Locations (1)

TianJinHH

Tianjin, Tianjin Municipality, China