- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06397638
Rescue Carotid Stenting in Tandem Occlusions: 4-year Experience From a Comprehensive Stroke Centre
June 20, 2024 updated by: Dr. Cuong Tran Chi, Can Tho Stroke International Services Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cần Thơ, Vietnam, 900000
- Can Tho SIS Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age > 18 years old
- Onset to treatment time < 24 hours
- NIHSS > 5
- DWI-ASPECTS ≥ 5
Exclusion Criteria:
- Premorbid mRS > 2
- Loss to follow-up after discharge
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Rescue carotid stenting
Rescue carotid stenting in tandem occlusions
|
Rescue carotid stenting in tandem occlusions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The good 3-month outcome rate
Time Frame: 3 months
|
The good 3-month outcome rate was accessed by modified Rankin Score (mRS ≤ 2).
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Cuong C Tran, PhD, Can Tho Stroke International Services General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Anadani 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.
- Zevallos 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2020
Primary Completion (Actual)
May 31, 2024
Study Completion (Actual)
May 31, 2024
Study Registration Dates
First Submitted
April 30, 2024
First Submitted That Met QC Criteria
April 30, 2024
First Posted (Actual)
May 3, 2024
Study Record Updates
Last Update Posted (Actual)
June 21, 2024
Last Update Submitted That Met QC Criteria
June 20, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Rescue carotid stenting
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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