NCT06843356Toboroz
Rescue Endovascular Treatment After Neurological Deterioration in Initially Mild Basilar Artery Occlusion in an Extended Time Window
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 16.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 159 (tervezett)
- Első benyújtás
- 2025. febr. 20.
- Kezdés
- 2025. aug. 1.
- Elsődleges befejezés
- 2027. szept. 30.
- Fő szponzor
- First Affiliated Hospital of Wannan Medical College
- Betegségek
- Stroke (szélütés)
- NCT-szám
- NCT06843356
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 159
- 2025. aug. 1. és az elsődleges befejezés (2027. szept. 30.) között
- 2 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Concurrent anterior and posterior circulation strokes.
- Prior imaging confirmed or investigator-assessed chronic basilar artery occlusion.
Más betegség
- 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, obstructive hydrocephalus, severe infection, high fever, heart or kidney dysfunction, hypovolemia, or severe electrolyte disturbances).
- 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.
- Presence of active bleeding, coagulation disorders, or uncorrectable bleeding tendencies.
- Severe heart, liver, or kidney dysfunction or other severe systemic late-stage diseases.
- Known allergy to iodine contrast agents or other treatment-related drugs.
- 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).
- 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).
Laborértékek
- Platelet count <40×10\^9/L, or INR >2 during anticoagulation therapy (irreversible).
- Uncontrollable blood glucose <2.8 mmol/L or >22.2 mmol/L.
Egyéb
- prestroke mRS >2.
- Factors in the target vessel that are expected to prevent completion of endovascular treatment.
- Presence of untreated intracranial aneurysms, intracranial tumors (except small meningiomas), or intracranial vascular malformations.
- Pregnancy or breastfeeding.
- Life expectancy <6 months.
- Participation in other clinical studies that may affect outcome assessment.
Kiket keres a vizsgálat
- Age ≥18 years.
- Initially mild ischemic stroke, defined as an initial NIHSS score <6, with no prior endovascular treatment for the index ischemic event.
- Basilar artery occlusion, or vertebral artery occlusion resulting in complete interruption of antegrade flow into the basilar artery, documented by CTA, MRA, or DSA during the initially mild phase and before qualifying neurological deterioration.
- Qualifying neurological deterioration occurring between 24 hours and 7 days after initial symptom onset, or after the last known well if symptom onset is unknown.
- Qualifying neurological deterioration is defined as an NIHSS score ≥10 with either a ≥4-point increase in total NIHSS or a ≥2-point increase in the NIHSS level-of-consciousness score from the initial NIHSS score and must be documented by certified medical personnel at a medical facility, including a referring hospital.
- Posterior circulation Acute Stroke Prognosis Early CT Score (pc-ASPECTS) ≥6 on noncontrast CT or diffusion-weighted MRI performed after qualifying neurological deterioration.
- Time from qualifying neurological deterioration to randomization ≤24 hours.
- Written informed consent obtained from the patient or a legally authorized representative.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (2)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| The First Affiliated Hospital of the University of Science and Technology of China | Hefei | Kína | Toboroz |
| First Affiliated Hospital of Wannan Medical College | Wuhu | Kína | Toboroz |
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