NCT05735301 Patient Selection Using MR With Non-Perfusion Imaging for Endovascular Treatment Within 6 to 24 Hours
| NCT ID | NCT05735301 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tianjin Huanhu Hospital |
| Condition | Endovascular Thrombectomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 352 participants |
| Start Date | 2019-01-01 |
| Primary Completion | 2024-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 352 participants in total. It began in 2019-01-01 with a primary completion date of 2024-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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).
Contact & Investigator
Ming Wei, doctorate
PRINCIPAL INVESTIGATOR
Tianjin Huanhu Hospital
Frequently Asked Questions
Who can join the NCT05735301 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Endovascular Thrombectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05735301 currently recruiting?
Yes, NCT05735301 is actively recruiting participants. Contact the research team at drweiming@163.com for enrollment information.
Where is the NCT05735301 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT05735301 clinical trial?
NCT05735301 is sponsored by Tianjin Huanhu Hospital. The principal investigator is Ming Wei, doctorate at Tianjin Huanhu Hospital. The trial plans to enroll 352 participants.