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 (MIELS)

NCT05735301 NA RECRUITING

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.

Details

Lead sponsor	Tianjin Huanhu Hospital
Phase	NA
Status	RECRUITING
Enrolment	352
Start date	2019-01-01
Completion	2024-09

Conditions

• Endovascular Thrombectomy

Interventions

• Endovascular
• Drug

Primary outcomes

• Functionally independent outcome in all enrolled patients — 90 days
  defined as patients with a mRS Score of 0-2 at 90 days (mRS 90d(Scores on the modified Rankin scale range from 0 to 6, with 0 indicating no symptoms, 1 no clinically significant disability, 2 slight disability, 3 moderate disability, 4 moderately severe disability, 5 severe disability, and 6 death,) of a randomized group of modified intention-to-treat (mITT) patients (defined as patients with acute macrovascular occlusions treated optimally with endovascular or pharmacologic therapy) at 90 days (with an assessment time window of ±14 days) and analyzed for noninferiority.

Countries

China