Rescue Extracranial Vertebral Stenting in Tandem Occlusions

NCT ID: NCT06365294

Last Updated: 2024-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-31
• Study Completion Date: 2024-06-08

Brief 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

Detailed 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

Conditions

Acute Stroke; Ischemic Stroke, Acute; Vertebro Basilar Ischemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rescue extracranial vertebral stenting

Rescue extracranial vertebral stenting in tandem occlusions

Group Type: EXPERIMENTAL

Rescue extracranial stenting

Intervention Type: PROCEDURE

Rescue extracranial stenting in tandem occlusions

Interventions

Rescue extracranial stenting

Rescue extracranial stenting in tandem occlusions

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Cuong Tran Chi

OTHER

Sponsor Role: lead

Responsible Party

Dr. Cuong Tran Chi

Director - Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Can Tho Stroke International Services Hospital

Role: STUDY_DIRECTOR

Can Tho Stroke International Services General Hospital

Locations

Can Tho SIS Hospital

Can Tho, , Vietnam

Countries

Vietnam

References

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.

Reference Type: BACKGROUND

PMID: 27522497 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38277540 (View on PubMed)

Other Identifiers

REVET Study

Identifier Type: -

Identifier Source: org_study_id