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

NCT05735301 | Recruiting DMC

• 1 other identifier: wm-v1003
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endovascular Thrombectomy

Keywords

select patients; endovascular thrombectomy; magnetic resonance imaging; CT/MR perfusion; FVH-DWI mismatch

Outcome Measures

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.

  90 days

Secondary Outcomes (9)

• Modified Rankin scale scores at 90 days

  90 days

• Successful reperfusion after endovascular treatment

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

• Recanalization rate

  72 hours

• Final infarct volume

  72hours

• NIHSS score

  24 hours、72hour sand 7 days postoperatively

Study Arms (2)

Non-Perfusion group

OTHER

Non-Perfusion group consisted of patients who underwent DWI, FLAIRE, T1, and T2 sequences.The patients in the group whose MR imaging show FVH-DWI mismatch will be perfomed EVT(stent retrievers, contact aspiration, balloon angioplasty, stenting or a combination of these approaches) and best medical treatment; Patients who do not reach FVH-DWI mismatch due to image quality, EVT will be re-judged according to the DAWN criteria, Others will be given best medical treatment）

Procedure: Endovascular; Drug: Drug

Perfusion group

OTHER

The perfusion sequence was examined by the group.The patients in the group whose F-Stroke(Brain Seal Smart Technology) indicate CBV\<70mL,mismatch ratio≥1.8 mismatch Volume\>15ml will be perfomed EVT and then received best medical treatment, others will be given best medical treatment only.

Procedure: Endovascular; Drug: Drug

Interventions

Endovascular PROCEDURE

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

Non-Perfusion group; Perfusion group

Drug DRUG

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

Also known as: Drug conservative therapy

Non-Perfusion group; Perfusion group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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；
• Time from stroke onset to randomization within 6-24 hours；
• Pre-stroke mRS score 0-2；
• Completed MRI and perfusion imaging or enable to complete MRI and/or perfusion imaging；
• Signed informed consent

You may not qualify if:

• 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)；
• Active hemorrhage or preexisting tendency to hemorrhage；
• Presence of signs of cardiac, hepatic or renal failure；
• Baseline blood glucose\<50mg/dL (2.78mmol) or \>400mg/dL (22.20mmol)；
• Participation in other interventional randomized clinical trials that may confound the outcome assessment of the trial；
• Life expectancy \< 1 year；
• Patients who are unable to complete the 90-day follow-up；
• A stroke attack with epilepsy that prevents an accurate NIHSS score from being obtained；
• Other circumstances that the investigator considers inappropriate for participation in the trial(such as violation of guidelines or institutional processing principles during the screening process).

Sponsors & Collaborators

• Tianjin Huanhu Hospital: lead

Study Sites (1)

TianJinHH

Tianjin, Tianjin Municipality, 300222, China

RECRUITING

MeSH Terms

Interventions

Pharmaceutical Preparations

Study Officials

• Ming Wei, doctorate

  Tianjin Huanhu Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Wei, doctorate

CONTACT

13502182903; drweiming@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The investigators will know nothing about the patient's image result until randomization. Outcome analysis was performed by an independent statistician, and results were reported directly to the data and safety regulatory committee, the investigator being aware of the results at this time.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Neurosurgery, Principal Investigator, Clinical Professor

Model Details: In this study, Patients will be screened, and image modality seletion be randomizied by a dedicated Clinical coordinator who is a non-treatment and non-follow-up participant. The randomization procedure will be computer- and web-based. Randomization is allowed when the occlusion has been established by MRA or CTA. All eligible subjects will be assigned to one of the following two treatment arms in the ratio of 1:1 after randomization: 1. None-Perfusion group. 2. Perfusion group.

Study Record Dates

• First Submitted: October 9, 2022
• First Posted: February 21, 2023
• Study Start: January 1, 2019
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: June 24, 2024

Record last verified: 2024-06

Locations

CN (1)