Randomized Clinical Trial of Endovascular Treatment for Progressive Stroke With Vertebrobasilar Artery Occlusion
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFeng Gao
About this trial
This multicenter, prospective, open-label randomized controlled trial with blinded assessment was designed to assess the efficacy and safety of endovascular treatment for progressive stroke due to vertebrobasilar artery occlusion.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
Acute ischemic stroke, with a National Institutes of Health Stroke Scale (NIHSS) score of <10 at initial symptom onset, and no prior endovascular treatment.
Stroke progression occurring from 24 hours to 14 days after initial symptom onset, defined as an NIHSS score of ≥10 with an increase of ≥4 points from baseline.
Acute basilar artery occlusion or dominant vertebral artery occlusion with contralateral occlusion or hypoplasia, confirmed by CTA, MRA or DSA.
Disqualifiers
Any sign of intracranial hemorrhage (except microbleeds) on baseline brain imaging.
Imaging confirms the progression of symptoms caused by intracranial hemorrhage, brain edema, or other clear causes.
Extensive cerebellar infarction with significant mass effect or bilateral thalamic infarction on baseline neuroimaging.
Presence of untreated intracranial aneurysm, intracranial tumor (except small meningioma and aneurysms <3 mm in diameter), or intracranial arteriovenous malformation.
Trial design
Design model
Parallel
Treatments tested in this trial
Endovascular Recanalization
Procedure/SurgeryThe endovascular approach is selected by the treating neurointerventionalists based on angiographic findings, occlusion characteristics, and procedural feasibility. Permitted techniques include mechanical thrombectomy using stent retriever and/or aspiration-based methods. Adjunctive endovascular procedures, such as balloon angioplasty, stent deployment, or intraarterial thrombolysis, may be used when deemed necessary to achieve or maintain vessel patency. Angiographic reperfusion is assessed during the procedure, and treatment is terminated once adequate revascularization is obtained. Subsequent medical therapy is individualized according to stroke mechanism, procedural findings, and post-treatment imaging.
Medical Therapy Alone
DrugMedical therapy consists of comprehensive evidence-based medical therapy for acute ischemic stroke, encompassing acute supportive care, neurological and physiological monitoring, etiological evaluation, and secondary prevention strategies. Standard pharmacological treatments are administered as appropriate, together with risk factor modification and supportive care measures, in accordance with current guideline recommendations. Endovascular recanalization procedures are not included in this treatment strategy.
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: Endovascular Treatment GroupExperimental treatment 1 intervention
Group B: Medical Therapy Alone GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The proportion of patients achieving modified Rankin Scale (mRS) score 0-3 at 90 days
The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability,5 severe disability, and 6 death.
Time frame
90±14 days after randomizationSecondary outcomes
1
Ordinal shift analysis of mRS score at 90 days after randomization
The modified Rankin Scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death.
Time frame
90±14 days after randomization2
The proportion of patients achieving mRS scores 0-1 and 0-2 at 90 days
The modified Rankin Scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death.
Time frame
90±14 days after randomization3
The National Institutes of Health Stroke Scale (NIHSS) score at 24 hours
National Institutes of Health Stroke Scale (NIHSS) score at 24 hours after randomization The National Institute of Health Stroke Scale (NIHSS) ranged from 0 to 42, with higher scores indicating greater neurologic deficits.
Time frame
24 (-6/+12) hours after randomization4
The NIHSS score at 7 days after randomization or discharge (whichever came first), as well as changes from baseline
NIHSS score at 7 days after randomization or discharge (whichever came first) The National Institute of Health Stroke Scale (NIHSS) ranged from 0 to 42, with higher scores indicating greater neurologic deficits.
Time frame
7 days after randomization or at dischargeOther outcomes
1
The rate of mortality within 90 days after randomization
All-cause mortality within 90 days after randomization.
Time frame
90±14 days after randomization2
The incidence of any symptomatic intracranial hemorrhage (sICH) defined as the Heidelberg classification within 24 hours
Heidelberg standard was defined as new intracranial hemorrhage detected by brain imaging associated with any of the item below: 4 points of total NIHSS score at the time of diagnosis compared to immediately before worsening. 2 points of NIHSS score in one category. Leading to intubation/hemicraniectomy/ventricular drainage placement or other major medical/surgical intervention. Absence of alternative explanation for deterioration.
Time frame
24 (-6/+12) hours after randomization3
The rate of any intracranial hemorrhage identified by CT or MRI imaging within 24 hours
Any intracranial hemorrhage identified by CT or MRI imaging within 24 hours.
Time frame
24 hours after randomization4
The rate of all-cause mortality within 7 days
The rate of all-cause mortality within 7 days after randomization.
Time frame
7 days after randomization or at dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Feng Gao
Lead sponsor
Beijing Tiantan Hospital
Sponsor institution
Source ClinicalTrials.gov
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