Acute StrokeESVONCT06129721
Emergent Stenting In Acute Vertebrobasilar Occlusions
A study testing Emergent Stenting in people with Acute Stroke and Ischemic Stroke, Acute, run by Can Tho Stroke International Services Hospital at 1 site in Vietnam.
Trial summary
In the acute posterior circulation strokes, the vertebrobasilar occlusions frequently related to worse outcomes than the anterior ones. However, few studies mentioned the benefit and safety of the emergent stenting in the successful recanalization at these complex occlusions. Read more about this study
- Who is it for?
- Ages 19 to 100 years
- Conditions the study is for
- Acute Stroke, Ischemic Stroke, Acute, Vertebro Basilar Ischemia
- What is being tested?
- Emergent Stenting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Dec 2020to 16 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- Onset to treatment time < 24 hours
- NIHSS ≥ 10
- pc-ASPECTS ≥ 5 on MRI
Who cannot join
- Premorbid mRS > 2
- Extensive, bilateral brain-stem infarction on neuroimaging
- Cerebellar mass effect on neuroimaging
Trial locations and contacts
1 site in 1 country.
About this study
In the acute posterior circulation strokes, the vertebrobasilar occlusions frequently related to worse outcomes than the anterior ones. However, few studies mentioned the benefit and safety of the emergent stenting in the successful recanalization at these complex occlusions. The investigators investigated whether the improvement of clinical outcome was achieved in postprocedural 3-month.
Read the detailed description
Acute ischemic stroke in posterior circulation account for nearly 20 - 25%, in which large vessel occlusions (LVOs) occur 0.8% - 5.7%. Although mechanical thrombectomy (MT) has recently been the gold standard in LVOs treatment, the futile recanalization (defined as unfavorable outcome despite early successful recanalization of target artery) rate was showed in posterior circulation higher than in anterior one. Multiple randomized controlled trials (BEST, BASICS, BAOCHE, ATTENTION) have recently reported the benefit of endovascular treatment better than of standard medical treatment for acute vertebrobasilar occlusions stroke. Besides, up to 36% LVOs with underlying intracranial stenosis and 64% with tandem lesions occured in the acute vertebrobasilar stroke. This was a reason why emergent stenting was considered to support the successful recanalization in the setting of failure of mechanical thrombectomy. Moreover, the successful recanalization is one of the independent predictors of good outcomes. However, the use of the loading dose dual antiplatelet therapy and peri-procedural complications made the safety of emergent stenting remain uncertain. Therefore, we aimed to investigate whether the impact of emergent stenting on the improved clinical outcome in vertebrobasilar occlusions.
- Being tested
- Emergent Stenting
- Keywords
- vertebrobasilar occlusions, acute ischemic stroke, emerging stenting
- Medical subject headings
- Stroke, Ischemic Stroke, Vertebrobasilar Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergent StentingProcedure or surgery
Also called ES
Emergent Stenting In Acute Vertebrobasilar Occlusions
| Study group | Role | What they receive |
|---|---|---|
| Emergent Stenting | Experimental | Emergent Stenting In Acute Vertebrobasilar Occlusions Receives: Procedure: Emergent Stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
The favorable 3-month outcome rate
The favorable 3-month outcome rate was accessed by modified Rankin Score (mRS), which comprised of included good (mRS 0 - ≤ 2) and fair (mRS 3).
Measured: 3 months
Secondary outcomes (1)
The symptomatic intracerebral hemorrhage rate
The symptomatic intracerebral hemorrhage was defined as patient's intracerebral hemorrhage with postprocedural mRS ≥ 5 and there were no other evident causes for the increased mRS
Measured: 24 hours after emergent stenting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Dec 2020
- Primary completion5 Jan 2024
- Study completion16 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Can Tho Stroke International Services Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Cuong Tran Chi, Can Tho Stroke International Services Hospital
- Investigators
- Cuong Tran Chi, Doctor, Study director, Can Tho Stroke International Services General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129721
- Sponsor's protocol ID
- ESVO Study
- Acronym
- ESVO
- Status last verified
- Feb 2024
- First submitted
- 8 Nov 2023
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tran CC, Le MT, Baxter BW, Nguyen-Luu G, Ngo MT, Nguyen-Dao NH, Duong-Hoang L, Mai-Van M, Nguyen MD. Rescue intracranial stenting in acute ischemic stroke: a preliminary Vietnamese study. Eur Rev Med Pharmacol Sci. 2022 Oct;26(19):6944-6952. doi: 10.26355/eurrev_202210_29875.
PubMed 36263574Le MT, Tran CC, Nguyen-Luu G, Ngo MT, Nguyen-Dao NH, Duong-Hoang L, Mai-Van M, Nguyen MD. Rescue stenting after the failure of intravenous thrombolysis and bridging thrombolysis: an initial Vietnamese report. Eur Rev Med Pharmacol Sci. 2022 Dec;26(24):9162-9169. doi: 10.26355/eurrev_202212_30667.
PubMed 36591828
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergent Stenting In Acute Vertebrobasilar Occlusions
- ClinicalTrials.gov ID
- NCT06129721
- Acronym / sponsor ID
- ESVO / ESVO Study
- Keywords
- vertebrobasilar occlusions, acute ischemic stroke, emerging stenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Can Tho Stroke International Services HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 16 Feb 2024 (actual)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the acute posterior circulation strokes, the vertebrobasilar occlusions frequently related to worse outcomes than the anterior ones. However, few studies mentioned the benefit and safety of the emergent stenting in the successful recanalization at these complex occlusions. The investigators investigated whether the improvement of clinical outcome was achieved in postprocedural 3-month.
Detailed description
Acute ischemic stroke in posterior circulation account for nearly 20 - 25%, in which large vessel occlusions (LVOs) occur 0.8% - 5.7%. Although mechanical thrombectomy (MT) has recently been the gold standard in LVOs treatment, the futile recanalization (defined as unfavorable outcome despite early successful recanalization of target artery) rate was showed in posterior circulation higher than in anterior one. Multiple randomized controlled trials (BEST, BASICS, BAOCHE, ATTENTION) have recently reported the benefit of endovascular treatment better than of standard medical treatment for acute vertebrobasilar occlusions stroke. Besides, up to 36% LVOs with underlying intracranial stenosis and 64% with tandem lesions occured in the acute vertebrobasilar stroke. This was a reason why emergent stenting was considered to support the successful recanalization in the setting of failure of mechanical thrombectomy. Moreover, the successful recanalization is one of the independent predictors of good outcomes. However, the use of the loading dose dual antiplatelet therapy and peri-procedural complications made the safety of emergent stenting remain uncertain. Therefore, we aimed to investigate whether the impact of emergent stenting on the improved clinical outcome in vertebrobasilar occlusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emergent Stenting | Experimental | Procedure: Emergent StentingEmergent Stenting In Acute Vertebrobasilar Occlusions |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years old
- Onset to treatment time < 24 hours
- NIHSS ≥ 10
- pc-ASPECTS ≥ 5 on MRI
Key exclusion criteria (3 listed)
- Premorbid mRS > 2
- Extensive, bilateral brain-stem infarction on neuroimaging
- Cerebellar mass effect on neuroimaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emergent StentingAlso: ESEmergent Stenting In Acute Vertebrobasilar Occlusions | Procedure or surgery | Emergent Stenting |
Primary outcome
The favorable 3-month outcome rate
Time frame: 3 months
The favorable 3-month outcome rate was accessed by modified Rankin Score (mRS), which comprised of included good (mRS 0 - ≤ 2) and fair (mRS 3).
1 secondary outcome
The symptomatic intracerebral hemorrhage rate
Time frame: 24 hours after emergent stenting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Background: PubMed 36263574Tran CC, Le MT, Baxter BW, Nguyen-Luu G, Ngo MT, Nguyen-Dao NH, Duong-Hoang L, Mai-Van M, Nguyen MD. Rescue intracranial stenting in acute ischemic stroke: a preliminary Vietnamese study. Eur Rev Med Pharmacol Sci. 2022 Oct;26(19):6944-6952. doi: 10.26355/eurrev_202210_29875.
- Background: PubMed 36591828Le MT, Tran CC, Nguyen-Luu G, Ngo MT, Nguyen-Dao NH, Duong-Hoang L, Mai-Van M, Nguyen MD. Rescue stenting after the failure of intravenous thrombolysis and bridging thrombolysis: an initial Vietnamese report. Eur Rev Med Pharmacol Sci. 2022 Dec;26(24):9162-9169. doi: 10.26355/eurrev_202212_30667.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cuong Tran Chi, Doctor study director
Can Tho Stroke International Services General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emergent Stenting in people with Acute Stroke and Ischemic Stroke, Acute, run by Can Tho Stroke International Services Hospital at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The favorable 3-month outcome rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06129721, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.