Acute StrokeTOESISNCT06120218
Tandem Occlusion After Emergent Stenting in Acute Ischemic Stroke
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 acute ischemic stroke due to tandem occlusion, the emergent stenting has recently become an endovascular treatment option combining with mechanical thrombectomy to achieve recanalization. However, the data on the beneficial endovascular management of tandem occlusion in two circulations is still limited. Read more about this study
- Who is it for?
- Ages 19 to 100 years
- Conditions the study is for
- Acute Stroke, Ischemic Stroke, Acute
- 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
- 110 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Dec 2020to 30 Nov 2025
- 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
- Premorbid mRS < 2
- NIHSS > 5
- ASPECTS ≥ 5 or pc-ASPECTS ≥ 5
Who cannot join
- Onset to treatment time > 24 hours
- Loss to follow up after discharge
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
Can Tho Stroke International Services Hospital
Can Tho, 900000
Cuong Tran Chi, Doctor, +84886559911, drcuongtran@dotquy.vn
About this study
Official title: Tandem Occlusion After Emergent Stenting in Acute Ischemic Stroke: Preliminary Experience From a Vietnamese Comprehensive Stroke Centre
In acute ischemic stroke due to tandem occlusion, the emergent stenting has recently become an endovascular treatment option combining with mechanical thrombectomy to achieve recanalization. However, the data on the beneficial endovascular management of tandem occlusion in two circulations is still limited. The purpose of our study was to compare the improvement of clinical outcome between two circulations after emergent stenting at 3 months.
Read the detailed description
The posterior circulation (about 20 - 25%) is less frequent than the anterior one in the acute ischemic stroke, but high mortality and morbidity in the acute vertebrobasilar thrombosis even successful recanalization are revealed. Besides, tandem occlusion is one of the complex lesions in large vessel occlusions relating to the poor outcome, particularly in the posterior circulation. Recent studies have suggested that emergent stenting could be used as an additional treatment to achieve permanent recanalization together with mechanical thrombectomy in the intracranial segments. Permanent recanalization is one of the most important factors that impact patient outcomes after acute ischemic stroke. However, although there are various approaches for this lesion, the comparision of the effectiveness in the two circulations remains unclear. Thus, the aims of our study were to compare baseline characteristics and clinical outcome of tandem occlusions between anterior and posterior circulation after emergent stenting in extracranial arteries.
- Conditions
- Acute Stroke, Ischemic Stroke, Acute
- Being tested
- Emergent Stenting
- Keywords
- Thrombectomy, Extracranial arteries, Endovascular treatment, Antegrade approach, Retrograde approach
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergent StentingProcedure or surgery
Emergent Stenting in acute ischemic stroke caused by tandem occlusions
| Study group | Role | What they receive |
|---|---|---|
| Emergent Stenting in Anterior circulation | Experimental | Emergent Carotid Stenting in acute ischemic stroke caused by tandem occlusions Receives: Procedure: Emergent Stenting |
| Emergent Stenting in Posterior circulation | Experimental | Emergent Extracranial Vertebral Stenting in acute ischemic stroke caused by tandem 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 modified Rankin Score (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 posted7 Nov 2023
- Study start1 Dec 2020
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
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
- NCT06120218
- Sponsor's protocol ID
- TOESIS Study
- Acronym
- TOESIS
- Status last verified
- Jun 2024
- First submitted
- 1 Nov 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Allard J, Delvoye F, Pop R, Labreuche J, Maier B, Marnat G, Sibon I, Zhu F, Lapergue B, Consoli A, Spelle L, Denier C, Richard S, Piotin M, Gory B, Mazighi M; ETIS Investigators. 24-Hour Carotid Stent Patency and Outcomes After Endovascular Therapy: A Multicenter Study. Stroke. 2023 Jan;54(1):124-131. doi: 10.1161/STROKEAHA.122.039797. Epub 2022 Dec 21.
PubMed 36542074Han 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 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tandem Occlusion After Emergent Stenting in Acute Ischemic Stroke: Preliminary Experience From a Vietnamese Comprehensive Stroke Centre
- ClinicalTrials.gov ID
- NCT06120218
- Acronym / sponsor ID
- TOESIS / TOESIS Study
- Conditions
- Acute Stroke, Ischemic Stroke, Acute
- Keywords
- Thrombectomy, Extracranial arteries, Endovascular treatment, Antegrade approach, Retrograde approach
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Can Tho Stroke International Services HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 7 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 acute ischemic stroke due to tandem occlusion, the emergent stenting has recently become an endovascular treatment option combining with mechanical thrombectomy to achieve recanalization. However, the data on the beneficial endovascular management of tandem occlusion in two circulations is still limited. The purpose of our study was to compare the improvement of clinical outcome between two circulations after emergent stenting at 3 months.
Detailed description
The posterior circulation (about 20 - 25%) is less frequent than the anterior one in the acute ischemic stroke, but high mortality and morbidity in the acute vertebrobasilar thrombosis even successful recanalization are revealed. Besides, tandem occlusion is one of the complex lesions in large vessel occlusions relating to the poor outcome, particularly in the posterior circulation. Recent studies have suggested that emergent stenting could be used as an additional treatment to achieve permanent recanalization together with mechanical thrombectomy in the intracranial segments. Permanent recanalization is one of the most important factors that impact patient outcomes after acute ischemic stroke. However, although there are various approaches for this lesion, the comparision of the effectiveness in the two circulations remains unclear. Thus, the aims of our study were to compare baseline characteristics and clinical outcome of tandem occlusions between anterior and posterior circulation after emergent stenting in extracranial arteries.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emergent Stenting in Anterior circulation | Experimental | Procedure: Emergent StentingEmergent Carotid Stenting in acute ischemic stroke caused by tandem occlusions |
| Emergent Stenting in Posterior circulation | Experimental | Procedure: Emergent StentingEmergent Extracranial Vertebral Stenting in acute ischemic stroke caused by tandem 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
- Premorbid mRS < 2
- NIHSS > 5
- ASPECTS ≥ 5 or pc-ASPECTS ≥ 5
Key exclusion criteria (2 listed)
- Onset to treatment time > 24 hours
- Loss to follow up after discharge
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 StentingEmergent Stenting in acute ischemic stroke caused by tandem occlusions | Procedure or surgery | Emergent Stenting in Anterior circulation, Emergent Stenting in Posterior circulation |
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Background: PubMed 36542074Allard J, Delvoye F, Pop R, Labreuche J, Maier B, Marnat G, Sibon I, Zhu F, Lapergue B, Consoli A, Spelle L, Denier C, Richard S, Piotin M, Gory B, Mazighi M; ETIS Investigators. 24-Hour Carotid Stent Patency and Outcomes After Endovascular Therapy: A Multicenter Study. Stroke. 2023 Jan;54(1):124-131. doi: 10.1161/STROKEAHA.122.039797. Epub 2022 Dec 21.
- 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
Related trials for Acute Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
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 2 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: status not confirmed, as of the sponsor's last update on 13 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cuong Tran Chi, Doctor (+84886559911, drcuongtran@dotquy.vn), or a site near the patient. 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 NCT06120218, 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 13 Jun 2024.