Acute StrokeREVETNCT06365294
Rescue Extracranial Vertebral Stenting in Tandem Occlusions
A study testing Rescue extracranial stenting in people with Acute Stroke and Ischemic Stroke, Acute, run by Dr. Cuong Tran Chi at 1 site in Vietnam.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Stroke, Ischemic Stroke, Acute, Vertebro Basilar Ischemia
- What is being tested?
- Rescue extracranial stenting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteVietnam
- Study dates
- 31 Dec 2020to 8 Jun 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 18 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 > 5
- pc-ASPECTS ≥ 5
Who cannot join
- Premorbid mRS > 2
- Extensive, bilateral brain-stem infarction on neuroimaging
- Cerebellar mass effect on neuroimaging
- Loss to follow-up
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Being tested
- Rescue extracranial stenting
- Keywords
- tandem occlusions, posterior circulation, rescue extracrnial 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.
Rescue extracranial stentingProcedure or surgery
Rescue extracranial stenting in tandem occlusions
| Study group | Role | What they receive |
|---|---|---|
| Rescue extracranial vertebral stenting | Experimental | Rescue extracranial vertebral stenting in tandem occlusions Receives: Procedure: Rescue extracranial stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
The good 3-month outcome rate
The good 3-month outcome rate was accessed by modified Rankin Score (mRS ≤ 2).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start31 Dec 2020
- Primary completion30 Apr 2024
- Study completion8 Jun 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Cuong Tran Chi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Cuong Tran Chi, Can Tho Stroke International Services Hospital
- Investigators
- Can Tho Stroke International Services Hospital, Study director, Can Tho Stroke International Services General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365294
- Sponsor's protocol ID
- REVET Study
- Acronym
- REVET
- Status last verified
- Jun 2024
- First submitted
- 10 Apr 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27522497Han 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.
PubMed 38277540
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rescue Extracranial Vertebral Stenting in Tandem Occlusions
- ClinicalTrials.gov ID
- NCT06365294
- Acronym / sponsor ID
- REVET / REVET Study
- Keywords
- tandem occlusions, posterior circulation, rescue extracrnial stenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Dr. Cuong Tran ChiUniversity, hospital or other
- Study start
- 31 Dec 2020 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 8 Jun 2024 (actual)
- First posted
- 15 Apr 2024 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rescue extracranial vertebral stenting | Experimental | Procedure: Rescue extracranial stentingRescue extracranial vertebral stenting in tandem occlusions |
Who may qualify
- Ages
- 18 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 > 5
- pc-ASPECTS ≥ 5
Key exclusion criteria (4 listed)
- Premorbid mRS > 2
- Extensive, bilateral brain-stem infarction on neuroimaging
- Cerebellar mass effect on neuroimaging
- Loss to follow-up
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 |
|---|---|---|
| Rescue extracranial stentingRescue extracranial stenting in tandem occlusions | Procedure or surgery | Rescue extracranial vertebral stenting |
Primary outcome
The good 3-month outcome rate
Time frame: 3 months
The good 3-month outcome rate was accessed by modified Rankin Score (mRS ≤ 2).
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 11 Jun 2024.
- Background: PubMed 27522497Cohen 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.
- Background: PubMed 38277540Han 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.
- 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.
Can Tho Stroke International Services Hospital 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 Rescue extracranial stenting in people with Acute Stroke and Ischemic Stroke, Acute, run by Dr. Cuong Tran Chi 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 4 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 11 Jun 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 good 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 NCT06365294, 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 11 Jun 2024.