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Trial of Rescue Endovascular Treatment for Progressive Acute Mild Ischemic Stroke With Basilar Artery Occlusion With Extended Time Window
Trial of Rescue Endovascular Treatment for Progressive Acute Mild Ischemic Stroke With Basilar Artery Occlusion With Extended Time Window
RecruitingNA
Sponsor: First Affiliated Hospital of Wannan Medical College
Conditions: Acute Mild Ischemic Stroke, Basilar Artery Occlusion, Rescue Endovascular Treatment, Extended Time Window
Interventions: Endovascular Treatment
Countries: China
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.
Eligibility overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: 1. Age ≥18 years. 2. 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. 3. Acute minor ischemic stroke, with a NIHSS score of \<6 at initial symptom onset, and no prior endovascular treatment. 4. Stroke progression occurring from 24 hours to 7 days after initial symptom onset, defined as an NIHSS score of ≥10 with an increase of ≥4 points from baseline. 5. Posterior circulation Alberta Stroke Program Early CT Score (pc-ASPECTS) of ≥6 on CT/magnetic resonance imaging (MRI) performed after the Stroke progression. 6. Time from stroke progression to randomization ≤24 hours. 7. Written informed consent is obtained from the patient or the patient's legally authorized representative, or enrollment proceeds under an emergency consent or deferred consent procedure approved by the institutional review board (IRB). Exclusion Criteria: 1. 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). 2. prestroke mRS \>2. 3. Factors in the target vessel that are expected to prevent completion of endovascular treatment. 4. Concurrent anterior and posterior circulation strokes. 5. Prior imaging confirmed or investigator-assessed chronic basilar artery occlusion. 6. Presence of untreated intracranial aneurysms, intracranial tumors (except small meningiomas), or intracranial vascular malformations. 7. Intracranial hemorrhage within the past 6 months, including parenchymal brain hemorrhage, intraventricular hemorrhage, or subarachnoid hemorrhage. 8. Gastrointestinal or urinary tract bleeding, acute myocardial infarction, cranial trauma, or major surgery within the past month. 9. Presence of active bleeding, coagulation disorders, or uncorrectable bleeding tendencies. 10. Platelet count \<40×10\^9/L, or INR \>2 during anticoagulation therapy (irreversible). 11. Severe heart, liver, or kidney dysfunction or other severe systemic late-stage diseases. 12. Known allergy to iodine contrast agents or other treatment-related drugs. 13. Medically uncontrolled refractory hypertension (defined as persistent systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg) (Note: Participants can be included if their blood pressure is controllable with medication and maintained at an acceptable level). 14. Uncontrollable blood glucose \<2.8 mmol/L or \>22.2 mmol/L. 15. Pregnancy or breastfeeding. 16. Life expectancy \<6 months. 17. Participation in other clinical studies that may affect outcome assessment. 18. Investigator's judgment that the patient is unsuitable for participation in this study or may face significant risks (e.g., due to mental illness, cognitive, or emotional disorders preventing understanding and/or compliance with study procedures and/or follow-up).
Locations (2)
- Hefei, Anhui, China
- Wuhu, Anhui, China