Endovascular ThrombectomyTRACK-LVO LateNCT06200753
Triage of Patients Presenting Beyond 24 Hours With Acute Ischemic Stroke Due to Large Vessel Occlusions (TRACK-LVO Late)
An observational study of Endovascular Thrombectomy and Large Vessel Occlusion, run by Tianjin Huanhu Hospital at 1 site in China.
Trial summary
The objective of this study is to create a comprehensive, multi-center, TRACK-LVO registry-linked cohort of consecutive patients with acute ischemic stroke (AIS) caused by large vessel occlusions (LVO) and presenting to each participating center beyond 24 hours from last known well, who are treated with either… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Endovascular Thrombectomy, Large Vessel Occlusion, Acute Ischemic Stroke
- What is being tested?
- Mechanical Thrombectomy
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2028
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Acute stroke patients with large vessel occlusion and presenting beyond 24 hours from last known well
Who may be able to join
- Patient admitted from Jan. 1st 2018 to Jan. 1st 2028;
- Presenting beyond 24 hours from last known well;
- Ischemic stroke confirmed by head CT or MRI;
- Large vessel occlusion confirmed by head CTA or MRA: intracranial internal carotid artery (ICA), middle cerebral artery (MCA M1/M2), anterior cerebral artery (ACA A1/A2), basilar artery (BA), vertebral artery (VA), and posterior cerebral artery (PCA P1/P2);
- Patients receiving either endovascular therapy or best medical treatment.
Who cannot join
- Presence of any forms of cerebral hemorrhage on CT/MR at admission.
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 Huanhu Hospital
Tianjin, Tianjin Municipality, 300070
Ming Wei, MD, PhD, 13502182903, drweiming@163.com
About this study
Official title: Triage of Patients Presenting Beyond 24 Hours From Last Known Well With Acute Ischemic Stroke Due to Large Vessel Occlusions (TRACK-LVO Late): a TRACK-LVO Registry-linked Cohort
The objective of this study is to create a comprehensive, multi-center, TRACK-LVO registry-linked cohort of consecutive patients with acute ischemic stroke (AIS) caused by large vessel occlusions (LVO) and presenting to each participating center beyond 24 hours from last known well, who are treated with either endovascular therapy (EVT) or the best available medical management (BMM).
Read the detailed description
There is an abundance of evidence demonstrating the efficacy and safety of endovascular therapy (EVT) within 24 hours of stroke onset. However, the potential benefits of EVT beyond this time window remain uncertain. To address this knowledge gap, the investigators established a TRACK-LVO Late linked cohort, specifically designed to investigate the outcomes of EVT in patients with LVO presenting beyond 24 hours from last known well.
This cohort includes patients from the TRACK-LVO registry who received either EVT or best medical treatment (BMT) beyond 24 hours from symptom onset. The cohort focuses on patients with LVO in the anterior circulation, confirmed by magnetic resonance angiography (MRA), computed tomography angiography (CTA), or digital subtraction angiography (DSA) in the EVT group. To maximize the sample size in the BMT group, the investigators also included patients with LVO confirmed using transcranial Doppler and carotid ultrasonography, in addition to the aforementioned imaging modalities.
Consistent with the TRACK-LVO registry, LVO is defined as an occlusion of the intracranial internal carotid artery (ICA) , M1 and/or M2 segments of the middle cerebral artery (MCA), A1 and/or A2 segments of the anterior cerebral artery (ACA), any segments of vertebral artery (VA), basilar artery (BA), or P1 and/or P2 segments of the posterior cerebral artery (PCA).
The investigators collect comprehensive patient information, including baseline demographic profiles, imaging characteristics such as ischemic core volume and FVH-DWI mismatch, CT/MR perfusion parameters, and treatment-related complications, for both EVT and BMT groups. For patients in the EVT group, the investigators also obtained detailed information on the EVT procedure and angiographic images.
By establishing this cohort, the investigators aim to provide high-level evidence to guide the treatment of a subgroup of stroke patients who present beyond the current guideline-recommended time window for EVT. The findings will contribute to determining the superiority of EVT over BMT in ischemic stroke patients with LVO and extended time from symptom onset.
- Being tested
- Mechanical Thrombectomy
- Keywords
- Acute Ischemic Stroke, Endovascular Therapy,
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ThrombectomyProcedure or surgery
Also called Ischemic post-conditioning, Selective Hypohermia
Mechanical Thrombectomy: A stroke treatment method involving the use of a device to extract a blood clot from the blood vessels, restoring blood flow and reducing brain damage.
Ischemic Post-conditioning: After thrombectomy, a procedure involving inflating and deflating a balloon in situ for four cycles of 2 minutes each, reducing reperfusion injury and minimizing neural damage.
Selective Hypothermia: Administering cold saline either intra-arterially or within the cerebral sinus to lower brain temperature, mitigating ischemia-induced injury.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular therapy | Not described Receives: Procedure: Mechanical Thrombectomy | |
| Best medical treatment | Not described Receives: Procedure: Mechanical Thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified ranking scale (mRS) at 90 days
A 0-6 scale running from perfect health without symptoms to death.
Measured: 90 days
symptomatic intracranial hemorrhage
any hemorrhagic transformation on subsequent imaging associated with a neurological decline of at least 4 points increase on the NIHSS score
Measured: 72 hours
Secondary outcomes (3)
National Institutes of Health Stroke Scale (NIHSS) scores at 90 days
The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
Measured: 1, 3, 5 (or discharge), 7 (or discharge) and 90 days
Occurrence of periprocedural complications
Periprocedural complications include any intracranial hemorrhage, cerebral edema, brain herniation and pneumonia.
Measured: 72 hours
EuroQol five dimensions questionnaire (EQ-5D)
The EQ-5D comprises five questions on mobility, self care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem). A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 Jan 2018
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endovascular ThrombectomyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Huanhu Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Wei, Tianjin Huanhu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200753
- Sponsor's protocol ID
- TJHH-2023-WM28
- Acronym
- TRACK-LVO Late
- Status last verified
- Dec 2023
- First submitted
- 16 Dec 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triage of Patients Presenting Beyond 24 Hours From Last Known Well With Acute Ischemic Stroke Due to Large Vessel Occlusions (TRACK-LVO Late): a TRACK-LVO Registry-linked Cohort
- ClinicalTrials.gov ID
- NCT06200753
- Acronym / sponsor ID
- TRACK-LVO Late / TJHH-2023-WM28
- Keywords
- Acute Ischemic Stroke, Endovascular Therapy,
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tianjin Huanhu HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 Jan 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 objective of this study is to create a comprehensive, multi-center, TRACK-LVO registry-linked cohort of consecutive patients with acute ischemic stroke (AIS) caused by large vessel occlusions (LVO) and presenting to each participating center beyond 24 hours from last known well, who are treated with either endovascular therapy (EVT) or the best available medical management (BMM).
Detailed description
There is an abundance of evidence demonstrating the efficacy and safety of endovascular therapy (EVT) within 24 hours of stroke onset. However, the potential benefits of EVT beyond this time window remain uncertain. To address this knowledge gap, the investigators established a TRACK-LVO Late linked cohort, specifically designed to investigate the outcomes of EVT in patients with LVO presenting beyond 24 hours from last known well.
This cohort includes patients from the TRACK-LVO registry who received either EVT or best medical treatment (BMT) beyond 24 hours from symptom onset. The cohort focuses on patients with LVO in the anterior circulation, confirmed by magnetic resonance angiography (MRA), computed tomography angiography (CTA), or digital subtraction angiography (DSA) in the EVT group. To maximize the sample size in the BMT group, the investigators also included patients with LVO confirmed using transcranial Doppler and carotid ultrasonography, in addition to the aforementioned imaging modalities.
Consistent with the TRACK-LVO registry, LVO is defined as an occlusion of the intracranial internal carotid artery (ICA) , M1 and/or M2 segments of the middle cerebral artery (MCA), A1 and/or A2 segments of the anterior cerebral artery (ACA), any segments of vertebral artery (VA), basilar artery (BA), or P1 and/or P2 segments of the posterior cerebral artery (PCA).
The investigators collect comprehensive patient information, including baseline demographic profiles, imaging characteristics such as ischemic core volume and FVH-DWI mismatch, CT/MR perfusion parameters, and treatment-related complications, for both EVT and BMT groups. For patients in the EVT group, the investigators also obtained detailed information on the EVT procedure and angiographic images.
By establishing this cohort, the investigators aim to provide high-level evidence to guide the treatment of a subgroup of stroke patients who present beyond the current guideline-recommended time window for EVT. The findings will contribute to determining the superiority of EVT over BMT in ischemic stroke patients with LVO and extended time from symptom onset.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular therapy | – | Procedure: Mechanical Thrombectomy |
| Best medical treatment | – | Procedure: Mechanical Thrombectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Acute stroke patients with large vessel occlusion and presenting beyond 24 hours from last known well
Key inclusion criteria (5 listed)
- Patient admitted from Jan. 1st 2018 to Jan. 1st 2028;
- Presenting beyond 24 hours from last known well;
- Ischemic stroke confirmed by head CT or MRI;
- Large vessel occlusion confirmed by head CTA or MRA: intracranial internal carotid artery (ICA), middle cerebral artery (MCA M1/M2), anterior cerebral artery (ACA A1/A2), basilar artery (BA), vertebral artery (VA), and posterior cerebral artery (PCA P1/P2);
- Patients receiving either endovascular therapy or best medical treatment.
Key exclusion criteria (1 listed)
- Presence of any forms of cerebral hemorrhage on CT/MR at admission.
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 |
|---|---|---|
| Mechanical ThrombectomyAlso: Ischemic post-conditioning, Selective HypohermiaMechanical Thrombectomy: A stroke treatment method involving the use of a device to extract a blood clot from the blood vessels, restoring blood flow and reducing brain damage. Ischemic Post-conditioning: After thrombectomy, a procedure involving inflating and deflating a balloon in situ for four cycles of 2 minutes each, reducing reperfusion injury and minimizing neural damage. Selective Hypothermia: Administering cold saline either intra-arterially or within the cerebral sinus to lower brain temperature, mitigating ischemia-induced injury. | Procedure or surgery | Best medical treatment, Endovascular therapy |
Primary outcome
Modified ranking scale (mRS) at 90 days
Time frame: 90 days
A 0-6 scale running from perfect health without symptoms to death.
symptomatic intracranial hemorrhage
Time frame: 72 hours
any hemorrhagic transformation on subsequent imaging associated with a neurological decline of at least 4 points increase on the NIHSS score
3 secondary outcomes
National Institutes of Health Stroke Scale (NIHSS) scores at 90 days
Time frame: 1, 3, 5 (or discharge), 7 (or discharge) and 90 days
Occurrence of periprocedural complications
Time frame: 72 hours
EuroQol five dimensions questionnaire (EQ-5D)
Time frame: 1 year
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 Jan 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endovascular Thrombectomy and Large Vessel Occlusion, 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 5 inclusion and 1 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 Jan 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 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified ranking scale (mRS) at 90 days (time frame: 90 days). The study lists 2 primary outcomes in all. 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 Jan 2024.