Acute Ischemic StrokeNCT06290076
A Predictive Model and Scoring System for Severe Complications After Endovascular Thrombectomy
An observational study of Acute Ischemic Stroke and Endovascular Thrombectomy, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
To establish a predictive model and scoring system for predicting severe complications after thrombectomy. This scoring system can be used to identify high-risk patients after endovascular thrombectomy, guide the early use of adjunctive interventions, and provide reference for future clinical trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Endovascular Thrombectomy, Symptomatic Intracranial Hemorrhage
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 30 Sep 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: At least 1500 patients with anterior circulation acute ischemic stroke due to large vessel occlusion and received endovascular thrombectomy.
Who may be able to join
- Symptoms and signs compatible with ischemia in the anterior circulation
- Internal carotid artery occlusion or middle cerebral artery M1 and M2 segment occlusion confirmed by computed tomographic angiography (CTA)/ magnetic resonance angiography (MRA)/ digital subtraction angiography (DSA)
- Premorbid mRS ≤1;
- National Institutes of Health Stroke Score (NIHSS) ≥6 at admission;
- Onset to puncture time ≤24h;
- Treated with thrombectomy resulting in mTICI score ≥2b at end of the procedure.
Who cannot join
- Intracranial hemorrhage, aneurysm, and arteriovenous malformation before endovascular thrombectomy;
- Perioperative complications, including dissection and arterial perforation;
- Anticipated life expectancy <3 months;
- Critical baseline clinical, laboratory and imaging data are missing;
- Lack of follow-up results within 72 hours and 90 days after thrombectomy;
- Pregnant or lactating women;
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- Severe systemic diseases (e.g. advanced cancer), potentially interfering with prognosis;
- Allergy to contrast media and nitinol;
- Concurrent participation in a study that would interfere with the establishment of predictive models;
- Unable to complete the assessment due to mental disorders cognitive or emotional disorders before onset.
Trial locations and contacts
1 site in 1 country.
China1 site
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
About this study
Official title: A Predictive Model and Scoring System for Severe Complications After Endovascular Thrombectomy: a Retrospective, Multicenter, Observational Study
To establish a predictive model and scoring system for predicting severe complications after thrombectomy. This scoring system can be used to identify high-risk patients after endovascular thrombectomy, guide the early use of adjunctive interventions, and provide reference for future clinical trials.
Read the detailed description
Acute ischemic stroke (AIS) accounts for about 80% of all strokes. The focus of AIS treatment is to restore reperfusion of ischemic territory as soon as possible, promote neurological recovery, reduce disability rate and improve long-term survival rate. In recent years, a series of randomized clinical trials have proved that endovascular thrombectomy (EVT) is safe and effective in the treatment of anterior circulation AIS. EVT has been recommend as the first-line treatment for anterior circulation large vessel occlusion (LVO) stroke by guidelines.
Symptomatic intracranial hemorrhage (sICH) and malignant cerebral edema (MCE) are the two most common severe neurological complications, leading to brain tissue hypoxia and neurological dysfunction. Currently, there is a lack of prediction system to identify patients at high risk for severe complications, who can most likely benefit from adjuvant treatment after thrombectomy to improve patient functional independence and survival rate.
- Conditions
- Acute Ischemic Stroke, Endovascular Thrombectomy, Symptomatic Intracranial Hemorrhage, Malignant Cerebral Edema
- Keywords
- Acute Ischemic Stroke, Endovascular Thrombectomy, sICH, MCE
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Severe Complications Group | Patients with severe complications (including symptomatic intracranial hemorrhage and malignant cerebral edema) occurred within 72 hours after endovascular thrombectomy are classified into severe complications group. | |
| Non-Severe Complications Group | Patients without severe complications (including symptomatic intracranial hemorrhage and malignant cerebral edema) occurred within 72 hours after endovascular thrombectomy are classified into non-severe complications group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of severe complications
Severe complications include symptomatic intracranial hemorrhage (sICH) and malignant cerebral edema (MCE). SICH was defined as any intracranial hemorrhage on the non-contrast CT scan accompanied with clinical deterioration, as defined by a increase of ≥4 points in the NIHSS score, or that led to death and that was identified as the predominant cause of the neurologic deterioration.
MCE was defined as a malignant state in which neurological function deteriorates progressively due to brain edema after endovascular thrombectomy, causing disturbance of consciousness, anisocoria, and midline shift of 5 mm or more on imaging, leading to brain herniation or death. Midline shift was obtained by measuring the point of maximum deviation perpendicular to the line connecting the anterior and posterior attachment points of the falx cerebri.
Measured: Within 72 hours after thrombectomy
Secondary outcomes (7)
Rate of mRS score of 3-6
The mRS score range from 0 (no disability) to 6 (death)
Measured: 90 days (±7 days) after thrombectomy
Rate of mRS score of 5-6
The mRS score range from 0 (no disability) to 6 (death)
Measured: 90 days (±7 days) after thrombectomy
Rate of symptomatic intracranial hemorrhage
SICH was defined as any intracranial hemorrhage on the non-contrast CT scan accompanied with clinical deterioration, as defined by a increase of ≥4 points in the NIHSS score, or that led to death and that was identified as the predominant cause of the neurologic deterioration.
Measured: Within 72 hours after thrombectomy
Rate of malignant cerebral edema
MCE was defined as a malignant state in which neurological function deteriorates progressively due to brain edema after endovascular thrombectomy, causing disturbance of consciousness, anisocoria, and midline shift of 5 mm or more on imaging, leading to brain herniation or death. Midline shift was obtained by measuring the point of maximum deviation perpendicular to the line connecting the anterior and posterior attachment points of the falx cerebri.
Measured: Within 72 hours after thrombectomy
Change of NIHSS score
The NIHSS score range from 0 (no deficit) to 42 (maximum deficit)
Measured: 24-72 hours after thrombectomy versus admission
Rate of modified Rankin Scale (mRS) score of 0-2
The mRS score range from 0 (no disability) to 6 (death)
Measured: 90 days (±7 days) after thrombectomy
All-cause mortality
Death defined as a mRS score of 6
Measured: 90 days (±7 days) after thrombectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 Jan 2020
- Primary completion30 Jun 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290076
- Sponsor's protocol ID
- IAT-PROACT
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li Z, Hao J, Wen C, Cheng T, Zhao Y, Bai X, Guo X, Cao W, Li T, Min XL, Jiao L, Zhang L, Yang B. Predictive factors for very poor outcomes after endovascular thrombectomy in anterior circulation large vessel occlusion: a multicentre retrospective study in China. BMJ Open. 2025 Oct 23;15(10):e101244. doi: 10.1136/bmjopen-2025-101244.
PubMed 41130675
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Predictive Model and Scoring System for Severe Complications After Endovascular Thrombectomy: a Retrospective, Multicenter, Observational Study
- ClinicalTrials.gov ID
- NCT06290076
- Acronym / sponsor ID
- IAT-PROACT
- Conditions
- Acute Ischemic Stroke, Endovascular Thrombectomy, Symptomatic Intracranial Hemorrhage, Malignant Cerebral Edema
- Keywords
- Acute Ischemic Stroke, Endovascular Thrombectomy, sICH, MCE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 4 Mar 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.
To establish a predictive model and scoring system for predicting severe complications after thrombectomy. This scoring system can be used to identify high-risk patients after endovascular thrombectomy, guide the early use of adjunctive interventions, and provide reference for future clinical trials.
Detailed description
Acute ischemic stroke (AIS) accounts for about 80% of all strokes. The focus of AIS treatment is to restore reperfusion of ischemic territory as soon as possible, promote neurological recovery, reduce disability rate and improve long-term survival rate. In recent years, a series of randomized clinical trials have proved that endovascular thrombectomy (EVT) is safe and effective in the treatment of anterior circulation AIS. EVT has been recommend as the first-line treatment for anterior circulation large vessel occlusion (LVO) stroke by guidelines.
Symptomatic intracranial hemorrhage (sICH) and malignant cerebral edema (MCE) are the two most common severe neurological complications, leading to brain tissue hypoxia and neurological dysfunction. Currently, there is a lack of prediction system to identify patients at high risk for severe complications, who can most likely benefit from adjuvant treatment after thrombectomy to improve patient functional independence and survival rate.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Severe Complications Group | – | –Patients with severe complications (including symptomatic intracranial hemorrhage and malignant cerebral edema) occurred within 72 hours after endovascular thrombectomy are classified into severe complications group. |
| Non-Severe Complications Group | – | –Patients without severe complications (including symptomatic intracranial hemorrhage and malignant cerebral edema) occurred within 72 hours after endovascular thrombectomy are classified into non-severe complications group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- At least 1500 patients with anterior circulation acute ischemic stroke due to large vessel occlusion and received endovascular thrombectomy.
Key inclusion criteria (6 listed)
- Symptoms and signs compatible with ischemia in the anterior circulation
- Internal carotid artery occlusion or middle cerebral artery M1 and M2 segment occlusion confirmed by computed tomographic angiography (CTA)/ magnetic resonance angiography (MRA)/ digital subtraction angiography (DSA)
- Premorbid mRS ≤1;
- National Institutes of Health Stroke Score (NIHSS) ≥6 at admission;
- Onset to puncture time ≤24h;
Key exclusion criteria (10 listed)
- Intracranial hemorrhage, aneurysm, and arteriovenous malformation before endovascular thrombectomy;
- Perioperative complications, including dissection and arterial perforation;
- Anticipated life expectancy <3 months;
- Critical baseline clinical, laboratory and imaging data are missing;
- Lack of follow-up results within 72 hours and 90 days after thrombectomy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of severe complications
Time frame: Within 72 hours after thrombectomy
Severe complications include symptomatic intracranial hemorrhage (sICH) and malignant cerebral edema (MCE). SICH was defined as any intracranial hemorrhage on the non-contrast CT scan accompanied with clinical deterioration, as defined by a increase of ≥4 points in the NIHSS score, or that led to death and that was identified as the predominant cause of the neurologic deterioration. MCE was defined as a malignant state in which neurological function deteriorates progressively due to brain edema after endovascular thrombectomy, causing disturbance of consciousness, anisocoria, and midline shift of 5 mm or more on imaging, leading to brain herniation or death. Midline shift was obtained by measuring the point of maximum deviation perpendicular to the line connecting the anterior and posterior attachment points of the falx cerebri.
7 secondary outcomes
Rate of mRS score of 3-6
Time frame: 90 days (±7 days) after thrombectomy
Rate of mRS score of 5-6
Time frame: 90 days (±7 days) after thrombectomy
Rate of symptomatic intracranial hemorrhage
Time frame: Within 72 hours after thrombectomy
Rate of malignant cerebral edema
Time frame: Within 72 hours after thrombectomy
Change of NIHSS score
Time frame: 24-72 hours after thrombectomy versus admission
Rate of modified Rankin Scale (mRS) score of 0-2
Time frame: 90 days (±7 days) after thrombectomy
All-cause mortality
Time frame: 90 days (±7 days) after thrombectomy
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 4 Mar 2024.
- Derived from this study: PubMed 41130675Li Z, Hao J, Wen C, Cheng T, Zhao Y, Bai X, Guo X, Cao W, Li T, Min XL, Jiao L, Zhang L, Yang B. Predictive factors for very poor outcomes after endovascular thrombectomy in anterior circulation large vessel occlusion: a multicentre retrospective study in China. BMJ Open. 2025 Oct 23;15(10):e101244. doi: 10.1136/bmjopen-2025-101244.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Ischemic Stroke and Endovascular Thrombectomy, run by Xuanwu Hospital, Beijing 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 6 inclusion and 10 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 4 Mar 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?
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?
Rate of severe complications (time frame: Within 72 hours after thrombectomy). 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 NCT06290076, which also lists 1 linked publication.
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 4 Mar 2024.