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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTianjin Huanhu Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age of 18 years or older;

Anterior circulation LVO (internal carotid artery, or middle cerebral arteries (MCA)M1, M2 proximal segment) confirmed by computed tomographic angiography (CTA)/magnetic resonance angiography (MRA);

NIHSS score ≥6 at the time of randomization;

ASPECTS score ≥ 6 on NCCT;

Disqualifiers

Pregnancy, or those potential with positive urine or serum beta Human Chorionic Gonadotrop in test;

A history of severe allergy to contrast media;

Uncontrolled hypertension (SBP >185mmHg; DBP>110mmHg);

Hereditary or acquired bleeding tendency, coagulation factor deficiency, recent anticoagulant medication (A platelet count of less than 100 x 109 /L;INR>3 or PPT more than 3 times normal);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Endovascular

    Procedure/Surgery

    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

Treatment groups

352 Participants
are divided into 2 treatment groups
Group A: Non-Perfusion groupOther 2 interventions
Group B: Perfusion groupOther 2 interventions

Trial outcomes

Primary outcomes

1

Functionally independent outcome in all enrolled patients

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.

Time frame
90 days

Secondary outcomes

1

Modified Rankin scale scores 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.

Time frame
90 days
2

Successful reperfusion after endovascular treatment

extended Thrombolysis in Cerebral Infarction (eTICI) score of 2b, 2c or 3.

Time frame
immediately the surgeon thought the thrombectomy completed and performed a second cerebral angiography
3

Recanalization rate

Number of subjects who achieved successful reperfusion/total number of subjects who received endovascular treatment, confirmed by MRA, CTA, or digital subtraction angiography (DSA).

Time frame
72 hours
4

Final infarct volume

change from baseline in the infarct volume as calculated by CBF or DWI.

Time frame
72hours

Other outcomes

Sponsors and contacts

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