Trial of Rescue Endovascular Treatment for Progressive Acute Mild Ischemic Stroke With Basilar Ar… (NCT06843356) | Clinical Trial Compass
RecruitingNot Applicable
Trial of Rescue Endovascular Treatment for Progressive Acute Mild Ischemic Stroke With Basilar Artery Occlusion With Extended Time Window
China159 participantsStarted 2024-06-01
Plain-language summary
A prospective, multicenter, open-label, blinded-endpoint, randomized controlled trial to evaluate whether best medical management (BMM) combined with endovascular therapy (EVT) improves neurological outcomes compared to BMM alone in patients with progressive acute mild ischemic stroke due to basilar artery occlusion within an extended time window.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥18 years.
✓. Symptoms and signs consistent with basilar artery ischemia.
✓. Basilar artery or vertebral artery occlusion confirmed by computed tomography angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA); if vertebral artery occlusion is present, it should completely block blood flow along the basilar artery.
✓. First-time onset meeting the criteria for mild ischemic stroke diagnosis: NIHSS score \<6.
✓. Symptom progression within 7 days of the first onset.
✓. Symptom progression: NIHSS score increase ≥4 points or consciousness level increase ≥2 points from the initial NIHSS score.
✓. Time from symptom onset to randomization \>24 hours.
✓. Symptom progression to randomization time ≤24 hours.
Exclusion criteria
✕. Symptom progression due to intracranial hemorrhage, brain edema, or other clear causes (including but not limited to infarct hemorrhagic transformation, new infarction in non-occluded vascular regions, severe infection, high fever, heart or kidney dysfunction, hypovolemia, or severe electrolyte disturbances).
✕. mRS \>2.
✕. Factors in the target vessel that are expected to prevent completion of endovascular treatment.
What they're measuring
1
Proportion of patients with a modified Rankin Scale (mRS) score of 0-3 at 90 (±7) days after randomization.
Timeframe: 90 (±7)days after procedure
Trial details
NCT IDNCT06843356
SponsorFirst Affiliated Hospital of Wannan Medical College
✕. Prior imaging confirmed or investigator-assessed chronic basilar artery occlusion.
✕. Presence of untreated intracranial aneurysms, intracranial tumors (except small meningiomas), or intracranial vascular malformations.
✕. Intracranial hemorrhage within the past 6 months, including parenchymal brain hemorrhage, intraventricular hemorrhage, or subarachnoid hemorrhage.
✕. Gastrointestinal or urinary tract bleeding, acute myocardial infarction, cranial trauma, or major surgery within the past month.