Perfusion-guided endovascular treatment for medium-vessel ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) trial comparing endovascular treatment plus best medical care versus best medical care alone for acute ischemic stroke caused by medium-vessel occlusions. Eligible adults have confirmed MeVO on CTA/MRA, NIHSS ≥8, pre-stroke mRS ≤1, and a perfusion target mismatch on CTP or MR perfusion (ischemic core <70 mL, mismatch ratio >1.2, mismatch volume >10 mL). Patients are randomized within 24 hours of last-known-well and outcomes are measured with a blinded assessment of functional independence (mRS ≤1) at 90 days. The trial aims to determine if perfusion-guided selection can identify MeVO patients who benefit from endovascular therapy beyond standard care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age≥18 years old;
* Acute ischemic stroke symptom onset within 24 hours; including wake-up stroke and unwitnessed stroke, onset time refers to "last-seen normal time";
* Primary medium vessel occlusions confirmed by CTA/MRA, including non-dominant proximal M2 or mid-distal M2/M3 segments of the middle cerebral artery (MCA), A1/A2/A3 segments of the anterior cerebral artery (ACA), and P1/P2/P3 segments of the posterior cerebral artery (PCA) and responsible for the signs and symptoms of acute ischemic stroke;
* Pre-stroke modified Rankin scale (mRS) score ≤1;
* Baseline National Institutes of Health Stroke Scale (NIHSS) ≥8;
* Neuroimaging criteria: Target mismatch profile on CT perfusion or MRI+MR perfusion (ischemic core volume \<70 mL, mismatch rate \>1.2, mismatch volume \>10 mL);
* Written informed consent from patients or their legally authorized representatives.

Exclusion Criteria:

* Any evidence of intracranial hemorrhage on qualifying imaging;
* Known (serious) sensitivity to radiographic contrast agents, nickel, titanium metals or their alloys and unable to complete CTP/PWI;
* Known history of arterial tortuosity, pre-existing stent, other arterial disease and/or known disease at the arterial access site that would prevent the device from reaching the target vessel and/or preclude safe recovery after EVT;
* Radiological confirmed evidence of mass effect or intracranial tumour (except small meningioma);
* Clinical diagnosis of cerebral vasculitis;
* Evidence of vessel recanalization prior to randomisation;
* Severe comorbidities, which will likely prevent improvement or follow-up;
* Any terminal illness such that the patient would not be expected to survive more than 1 year;
* Hypodensity in \>1/3 MCA territory on non-contrast CT or significant hypodensity outside the current perfusion lesion suggesting distal clot migration (secondary MeVO);
* Multiple arterial occlusion;
* Pregnant women, nursing mothers, or reluctance to use effective contraceptive measures during the period of the trial;
* Unlikely to adhere to the trial protocol or follow-up;
* Participation in other interventional clinical trials within the previous 3 months.

Where it's running

• Beijing tiantan hospital
  Beijing, Beijing Municipality, China Recruiting
• Beijing Daxing District People's Hospital
  Beijing, Beijing Municipality, China Recruiting
• Xingtang County People's Hospital
  Longzhou, Hebei, China Recruiting
• Luoyang Yiluo Hospital
  Luoyang, Henan, China Recruiting
• People's Hospital of Queshan
  Panlong, Henan, China Recruiting
• Changle People's Hospital
  Changle, Shandong, China Recruiting

Study contacts

• Principal investigator: Yunyun Xiong, professor — Beijing Tiantan Hospital
• Study coordinator: Yunyun Xiong, professor
• Email: xiongyunyun@bjtth.org
• Phone: 86-10-59978350

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.