Acute StrokeNCT06397638
Rescue Carotid Stenting in Tandem Occlusions: 4-year Experience From a Comprehensive Stroke Centre
A study testing Rescue carotid 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
The rescue carotid stenting has recently been an additional treatment followed by mechanical thrombectomy in tandem occlusions of the anterior circulation. Nevertheless, there were few data to date that support this beneficial treatment in Asia. 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?
- Rescue carotid stenting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Dec 2020to 31 May 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 > 5
- DWI-ASPECTS ≥ 5
Who cannot join
- Premorbid mRS > 2
- Loss to follow-up after discharge
Trial locations and contacts
1 site in 1 country.
About this study
The rescue carotid stenting has recently been an additional treatment followed by mechanical thrombectomy in tandem occlusions of the anterior circulation. Nevertheless, there were few data to date that support this beneficial treatment in Asia. The investigators hypothesized that this treatment related to improvement of clinical outcomes after procedure.
Read the detailed description
The anterior circulation made commonly up 70-80% of all ischemic strokes. The mechanical thrombectomy is the gold treatment standard in acute ischemic stroke due to large vessel occlusion of anterior circulation. Tandem occlusions are one of the acute lesions relating to the high poor clinical outcome rate. Besides, tandem characteristic is a challenge to perform endovascular therapy and save procedural time in the restoration blood flow to the cerebral artery territory infarction. Many studies demonstrated the roles of rescue carotid stenting with either proximal-to-distal or distal-to-proximal approach in the successful recanalization of tandem occlusions. However, few studies analyzed in detail this beneficial treatment in Asia. Therefore, the investigators conducted this study to assess whether rescue carotid stenting in the tandem occlusions to improve clinical outcomes at 3 months.
- Conditions
- Acute Stroke, Ischemic Stroke, Acute
- Being tested
- Rescue carotid stenting
- Keywords
- tandem occlusions, rescue carotid stenting, anterior circulation
- 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.
Rescue carotid stentingProcedure or surgery
Rescue carotid stenting in tandem occlusions
| Study group | Role | What they receive |
|---|---|---|
| Rescue carotid stenting | Experimental | Rescue carotid stenting in tandem occlusions Receives: Procedure: Rescue carotid 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 posted3 May 2024
- Study start1 Dec 2020
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 90 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 C Tran, PhD, Principal investigator, Can Tho Stroke International Services General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397638
- Sponsor's protocol ID
- Rescue carotid stenting
- Status last verified
- Jun 2024
- First submitted
- 30 Apr 2024
- Last updated
- 21 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 36542074Zevallos CB, Farooqui M, Quispe-Orozco D, Mendez-Ruiz A, Dajles A, Garg A, Galecio-Castillo M, Patterson M, Zaidat O, Ortega-Gutierrez S. Acute Carotid Artery Stenting Versus Balloon Angioplasty for Tandem Occlusions: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2022 Jan 18;11(2):e022335. doi: 10.1161/JAHA.121.022335. Epub 2022 Jan 13.
PubMed 35023353Anadani M, Marnat G, Consoli A, Papanagiotou P, Nogueira RG, Siddiqui A, Ribo M, Spiotta AM, Bourcier R, Kyheng M, Labreuche J, de Havenon A, Sibon I, Dargazanli C, Arquizan C, Cognard C, Olivot JM, Anxionnat R, Audibert G, Mazighi M, Blanc R, Lapergue B, Richard S, Gory B; TITAN and ETIS Registry Investigators. Endovascular Therapy of Anterior Circulation Tandem Occlusions: Pooled Analysis From the TITAN and ETIS Registries. Stroke. 2021 Oct;52(10):3097-3105. doi: 10.1161/STROKEAHA.120.033032. Epub 2021 Aug 10.
PubMed 34372671
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rescue Carotid Stenting in Tandem Occlusions: 4-year Experience From a Comprehensive Stroke Centre
- ClinicalTrials.gov ID
- NCT06397638
- Acronym / sponsor ID
- Rescue carotid stenting
- Conditions
- Acute Stroke, Ischemic Stroke, Acute
- Keywords
- tandem occlusions, rescue carotid stenting, anterior circulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Can Tho Stroke International Services HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 3 May 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 rescue carotid stenting has recently been an additional treatment followed by mechanical thrombectomy in tandem occlusions of the anterior circulation. Nevertheless, there were few data to date that support this beneficial treatment in Asia. The investigators hypothesized that this treatment related to improvement of clinical outcomes after procedure.
Detailed description
The anterior circulation made commonly up 70-80% of all ischemic strokes. The mechanical thrombectomy is the gold treatment standard in acute ischemic stroke due to large vessel occlusion of anterior circulation. Tandem occlusions are one of the acute lesions relating to the high poor clinical outcome rate. Besides, tandem characteristic is a challenge to perform endovascular therapy and save procedural time in the restoration blood flow to the cerebral artery territory infarction. Many studies demonstrated the roles of rescue carotid stenting with either proximal-to-distal or distal-to-proximal approach in the successful recanalization of tandem occlusions. However, few studies analyzed in detail this beneficial treatment in Asia. Therefore, the investigators conducted this study to assess whether rescue carotid stenting in the tandem occlusions to improve clinical outcomes at 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rescue carotid stenting | Experimental | Procedure: Rescue carotid stentingRescue carotid stenting in 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
- Onset to treatment time < 24 hours
- NIHSS > 5
- DWI-ASPECTS ≥ 5
Key exclusion criteria (2 listed)
- Premorbid mRS > 2
- 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 |
|---|---|---|
| Rescue carotid stentingRescue carotid stenting in tandem occlusions | Procedure or surgery | Rescue carotid 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 21 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 35023353Zevallos CB, Farooqui M, Quispe-Orozco D, Mendez-Ruiz A, Dajles A, Garg A, Galecio-Castillo M, Patterson M, Zaidat O, Ortega-Gutierrez S. Acute Carotid Artery Stenting Versus Balloon Angioplasty for Tandem Occlusions: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2022 Jan 18;11(2):e022335. doi: 10.1161/JAHA.121.022335. Epub 2022 Jan 13.
- Background: PubMed 34372671Anadani M, Marnat G, Consoli A, Papanagiotou P, Nogueira RG, Siddiqui A, Ribo M, Spiotta AM, Bourcier R, Kyheng M, Labreuche J, de Havenon A, Sibon I, Dargazanli C, Arquizan C, Cognard C, Olivot JM, Anxionnat R, Audibert G, Mazighi M, Blanc R, Lapergue B, Richard S, Gory B; TITAN and ETIS Registry Investigators. Endovascular Therapy of Anterior Circulation Tandem Occlusions: Pooled Analysis From the TITAN and ETIS Registries. Stroke. 2021 Oct;52(10):3097-3105. doi: 10.1161/STROKEAHA.120.033032. Epub 2021 Aug 10.
- 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 C Tran, PhD principal investigator
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 carotid 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: finished, as of the sponsor's last update on 21 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 NCT06397638, which also lists 3 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 21 Jun 2024.