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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06365294
Other study ID # REVET Study
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 31, 2020
Est. completion date June 8, 2024

Study information

Verified date June 2024
Source Can Tho Stroke International Services Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The acute vertebrobasilar occlusion associated with the poor prognosis, particularly tandem occlusion. However, few data on the efficacy of the endovascular therapy was indicated in this occlusion. The investigators reported whether the additional rescue extracranial stenting improved clinical outcome by modified Rankin Scale (mRS) score within 3 months after the procedure


Description:

Acute vertebrobasilar artery occlusion is one of the cerebrovascular diseases with high disability and mortality rates. Although mechanical thrombectomy has recently been demonstrated an effective treatment for large vessel occlusions of posterior circulation, the treatment strategies depending on the specific pathophysiology. Tandem occlusion in posterior circulation is less frequently than in anterior one, comprises severe stenosis or occlusion of the extracranial vertebral artery ipsilateral to its intracranial and basilar occlusion. The recent studies showed the benefit of the "distal-to-proximal" approach, there were many tecniques to achieved the successful recanalization. Besides, the use of Dotter technique allowed 8F guiding catheter to cross the extracranial lesions easily and save the procedural time. However, the Diagnosis 5F-Dotter, like the Dilator-Dotter, has not been mentioned in previous studies. Therefore, the aim of the our study was to assess the improvement of outcomes at 3 months posttreatment in patients receiving rescue extracranial vertebral stenting


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date June 8, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Age > 18 years old - Onset to treatment time < 24 hours - NIHSS > 5 - pc-ASPECTS = 5 Exclusion Criteria: - Premorbid mRS > 2 - Extensive, bilateral brain-stem infarction on neuroimaging - Cerebellar mass effect on neuroimaging - Loss to follow-up

Study Design


Intervention

Procedure:
Rescue extracranial stenting
Rescue extracranial stenting in tandem occlusions

Locations

Country Name City State
Vietnam Can Tho SIS Hospital C?n Tho

Sponsors (1)

Lead Sponsor Collaborator
Dr. Cuong Tran Chi

Country where clinical trial is conducted

Vietnam, 

References & Publications (2)

Cohen JE, Leker RR, Gomori JM, Eichel R, Rajz G, Moscovici S, Itshayek E. Emergent revascularization of acute tandem vertebrobasilar occlusions: Endovascular approaches and technical considerations-Confirming the role of vertebral artery ostium stenosis as a cause of vertebrobasilar stroke. J Clin Neurosci. 2016 Dec;34:70-76. doi: 10.1016/j.jocn.2016.05.005. Epub 2016 Aug 10. — View Citation

Han N, Ma L, Zhao L, Xu G, Jia Y, Wang H. The Dilator-Dotter technique can successfully treat tandem lesions of posterior circulation. Medicine (Baltimore). 2024 Jan 26;103(4):e37044. doi: 10.1097/MD.0000000000037044. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The good 3-month outcome rate The good 3-month outcome rate was accessed by modified Rankin Score (mRS = 2). 3 months
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