StrokeCRTALVOSNCT07115511
Combined Recanalization Therapy for Acute Large Vessel Occlusion Stroke
A study testing Surgery in people with Stroke, run by Tianjin Huanhu Hospital at 1 site in China.
Trial summary
The purpose of this clinical trial is to evaluate the efficacy and safety of combined recanalization therapy in patients who cannot be recanalized by acute large vessel occlusive stroke. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-75.
- According to the current guidelines, there is a MT indication.
- Before stroke, mRS ≤2;
- ASPECTS ≥6;
- MCA occlusion, with or without ICA occlusion;
- MT unsuccessful, TICI score 0-1;
- Time from onset to craniotomy expected to be 24 hours or less;
- Post-awakening stroke with mismatch between the infarct zone and the penumbra zone;
Who cannot join
- Comorbid hemorrhagic vascular disease such as intracranial aneurysm or vascular malformation or other planned cerebrovascular surgery that may alter cerebral hemodynamics or lead to stroke;
- unstable angina or myocardial infarction, congestive heart failure within the previous 6 months;
- Pregnancy or perinatal period;
- Hematologic disorders resulting in coagulation disorders;
- Combination of other diseases with a life expectancy of less than 2 years; and
- previous treatment with intracranial or extracranial vascular bypass surgery;
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- allergy to iodine or X-ray contrast media, creatinine >3.0 mg/dl or other contraindications to arteriography;
- Uncontrolled diabetes mellitus, fasting blood sugar (FBS) >16.7 mmol/L;
- Uncontrolled hypertension with sitting systolic blood pressure >180 mmHg or sitting diastolic blood pressure >110 mmHg;
- Severe hepatic dysfunction, defined as serum alanine aminotransferase (ALT) and/or alanine aminotransferase (AST) >3 times the upper limit of normal;
- Platelets <100×109 /L.
- Received a clinical trial drug or device within 30 days prior to screening, or is participating in another clinical trial;
- contraindication to general anesthesia or craniotomy;
- other diseases or medical history that, in the investigator's judgment, may affect the efficacy or safety evaluation of this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Huahu Hospital
Tianjin, Tianjin Municipality, 300060
Gao Kaiming, +8618622301400, sunnygao_sg@163.com
About this study
The purpose of this clinical trial is to evaluate the efficacy and safety of combined recanalization therapy in patients who cannot be recanalized by acute large vessel occlusive stroke. The main questions it aims to answer are:
1、Proportion of subjects with mRs score of 0-1 at 90 days after surgery
Participants will:
1、In acute large vessel occlusive stroke, if traditional means cannot be recanalized, combined recanalization surgery (including arteriotomy and thrombectomy, cerebrovascular bypass surgery) is performed.
- Conditions
- Stroke
- Being tested
- Surgery
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Recombined recanalization surgery
| Study group | Role | What they receive |
|---|---|---|
| experiment group（surgical treatment） | Experimental | Not described Receives: Procedure: Surgery |
| control group（conservative therapy） | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with mRs score of 0-1 at 90 days after surgery
Measured: 90 days after recombined recanalization surgery
Secondary outcomes (4)
Changes in NIHSS score at 24 hours after surgery, 7 days after surgery, 30 days after surgery and 90 days after surgery compared with baseline;
Measured: 90 days after recombined recanalization surgery
The mRs score changed from baseline at 90 days after surgery
Measured: 90 days after recombined recanalization surgery
Change from baseline in MOCA score at 90 days after surgery
Measured: 90 days after recombined recanalization surgery
Change from baseline in MMSE score at 90 days after surgery
Measured: 90 days after recombined recanalization surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Dec 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Huanhu Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao Kaiming, Tianjin Huanhu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115511
- Sponsor's protocol ID
- CRTALVOS2025
- Other IDs
- tianjin Huanhu hospital
- Acronym
- CRTALVOS
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Recanalization Therapy for Acute Large Vessel Occlusion Stroke
- ClinicalTrials.gov ID
- NCT07115511
- Acronym / sponsor ID
- CRTALVOS / CRTALVOS2025
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Tianjin Huanhu HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 11 Aug 2025 (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 purpose of this clinical trial is to evaluate the efficacy and safety of combined recanalization therapy in patients who cannot be recanalized by acute large vessel occlusive stroke. The main questions it aims to answer are:
1、Proportion of subjects with mRs score of 0-1 at 90 days after surgery
Participants will:
1、In acute large vessel occlusive stroke, if traditional means cannot be recanalized, combined recanalization surgery (including arteriotomy and thrombectomy, cerebrovascular bypass surgery) is performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experiment group（surgical treatment） | Experimental | Procedure: Surgery |
| control group（conservative therapy） | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: 18-75.
- According to the current guidelines, there is a MT indication.
- Before stroke, mRS ≤2;
- ASPECTS ≥6;
- MCA occlusion, with or without ICA occlusion;
Key exclusion criteria (14 listed)
- Comorbid hemorrhagic vascular disease such as intracranial aneurysm or vascular malformation or other planned cerebrovascular surgery that may alter cerebral hemodynamics or lead to stroke;
- unstable angina or myocardial infarction, congestive heart failure within the previous 6 months;
- Pregnancy or perinatal period;
- Hematologic disorders resulting in coagulation disorders;
- Combination of other diseases with a life expectancy of less than 2 years; and
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 |
|---|---|---|
| SurgeryRecombined recanalization surgery | Procedure or surgery | experiment group（surgical treatment） |
Primary outcome
Proportion of subjects with mRs score of 0-1 at 90 days after surgery
Time frame: 90 days after recombined recanalization surgery
4 secondary outcomes
Changes in NIHSS score at 24 hours after surgery, 7 days after surgery, 30 days after surgery and 90 days after surgery compared with baseline;
Time frame: 90 days after recombined recanalization surgery
The mRs score changed from baseline at 90 days after surgery
Time frame: 90 days after recombined recanalization surgery
Change from baseline in MOCA score at 90 days after surgery
Time frame: 90 days after recombined recanalization surgery
Change from baseline in MMSE score at 90 days after surgery
Time frame: 90 days after recombined recanalization surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery in people with Stroke, run by Tianjin Huanhu Hospital at 1 site in China.
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 8 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 11 Aug 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gao Kaiming (+8618622301400, sunnygao_sg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with mRs score of 0-1 at 90 days after surgery (time frame: 90 days after recombined recanalization surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2025.