NCT05326932Completed
Large Artery Occlusion Treated in Extended Time With Mechanical Thrombectomy Trial
An Investigator Initiated and Conducted, Prospective, Multicenter, Randomized Outcome-blinded Study of Treating Mechanical Thrombectomy Exceeding 24 Hours in Patients With Acute Ischemic Stroke Due to Large Vessel Occlusion
Source: ClinicalTrials.gov · Last updated 23 Sept 2026
Brief summary (registry, in English)
A multi-center, prospective, randomized, open-label, adaptive group sequential designed, blinded endpoint assessment (PROBE) clinical trial of endovascular treatment among selected AIS
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 336 (actual)
- First submitted
- 29 Mar 2022
- Start date
- 3 Nov 2022
- Primary completion date
- 17 Mar 2026
- Lead sponsor
- Lili SONG
- Diseases
- Stroke
- NCT number
- NCT05326932
What you commit to
- Study type: Interventional
- Participants enrolled: 336
- From 3 Nov 2022 to the primary completion date, 17 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Considered unlikely to benefit from trial (e.g. advanced dementia, major pre-stroke disability (prior modified Rankins scale (mRS) ≥2), high likelihood of early death), as judged by the responsible treating clinician
- Known allergy to iodine, heparin, anaesthesia, or other definite contraindication to receiving endovascular treatment (EVT) procedure
Other illness
- Major co-morbid disease that could interfere with outcome assessments and follow-up (e.g. cancer, severe heart failure, kidney failure)
- Seizures at stroke onset or before randomization and baseline NIHSS scores cannot be accurately determined
- Severe, sustained hypertension that can not be controlled by medication (systolic BP \>220 mmHg or diastolic BP \>120 mmHg)
- EVT attempted after stroke onset
- Any other condition that, in the opinion of the investigator will pose a significant hazard to the subject if participating in the trial.
- Neuroimaging Exclusion Criteria
- Intracranial hemorrhage (ICH), including parenchymal hemorrhage, ventricular hemorrhage, subarachnoid hemorrhage, and subdural/exsanguination
- Evidence of intracranial malignant tumor
- Any other condition that may affect EVT procedure, like the tortuous vascular path the device is difficult to reach the target position or difficult to recover
Lab values
- Baseline blood glucose of \<50 mg/dL (2.78 mmol/L) or \>400 mg/dL (22.20 mmol/L)
- Baseline platelet count \< 50,000/uL
- Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with International normalized ratio (INR) \>3
Other
- Clinical Exclusion Criteria
- Pregnancy
- Unable to undergo a CTP
- Presumed septic embolus, suspicion of bacterial endocarditis
- Unlikely to participate in follow-up assessments
- Currently participating in another trial that may affect outcomes.
- Significant mass effect with midline shift
- Aortic dissection
- Intracranial stent implanted in the same vascular territory
- Occlusions in multiple vascular territories confirmed on Computerized tomography angiography (CTA)/ Magnetic resonance imaging angiography (MRA) (e.g. bilateral MCA occlusions, or an MCA and a basilar artery occlusion)
Who the study is looking for
- Age ≥18 years
- Present 24-72 hours of stroke onset or last seen well
- Clinical diagnosis of AIS due to anterior circulation LVO (from internal carotid artery (ICA) extracranial segment to middle cerebral artery (MCA) M1 and M2 segment) on brain imaging
- National Institute of Health stroke scale (NIHSS) ≥6 at randomisation
- Viable cerebral tissue on computerized tomography perfusion (CTP) assessed: infarct core volume \<50 mL, mismatch ratio ≥1.8, and mismatch volume ≥15 mL
- Written informed consent (by patient or proxy, according to local requirements)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Changhai Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
Related publications
- Mechanical Thrombectomy 24 to 72 Hours after Large-Vessel Ischemic Stroke.N Engl J Med · 2026 · PMID 42929656
This page is information, not medical advice. Discuss any trial with your doctor.