A Predictive Model and Scoring System for Severe Complications After Endovascular Thrombectomy

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.

Study Overview

• Status: Completed
• Conditions: Acute Ischemic Stroke; Endovascular Thrombectomy; Symptomatic Intracranial Hemorrhage; Malignant Cerebral Edema

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 Type: Observational
• Enrollment (Actual): 1500

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

At least 1500 patients with anterior circulation acute ischemic stroke due to large vessel occlusion and received endovascular thrombectomy.

Description

Inclusion Criteria:

1. Symptoms and signs compatible with ischemia in the anterior circulation
2. 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)
3. Premorbid mRS ≤1;
4. National Institutes of Health Stroke Score (NIHSS) ≥6 at admission;
5. Onset to puncture time ≤24h;
6. Treated with thrombectomy resulting in mTICI score ≥2b at end of the procedure.

Exclusion Criteria:

1. Intracranial hemorrhage, aneurysm, and arteriovenous malformation before endovascular thrombectomy;
2. Perioperative complications, including dissection and arterial perforation;
3. Anticipated life expectancy <3 months;
4. Critical baseline clinical, laboratory and imaging data are missing;
5. Lack of follow-up results within 72 hours and 90 days after thrombectomy;
6. Pregnant or lactating women;
7. Severe systemic diseases (e.g. advanced cancer), potentially interfering with prognosis;
8. Allergy to contrast media and nitinol;
9. Concurrent participation in a study that would interfere with the establishment of predictive models;
10. Unable to complete the assessment due to mental disorders cognitive or emotional disorders before onset.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 72 hours after thrombectomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of mRS score of 3-6	The mRS score range from 0 (no disability) to 6 (death)	90 days (±7 days) after thrombectomy
Rate of mRS score of 5-6	The mRS score range from 0 (no disability) to 6 (death)	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.	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.	Within 72 hours after thrombectomy
Change of NIHSS score	The NIHSS score range from 0 (no deficit) to 42 (maximum deficit)	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)	90 days (±7 days) after thrombectomy
All-cause mortality	Death defined as a mRS score of 6	90 days (±7 days) after thrombectomy

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: February 7, 2024
• First Submitted That Met QC Criteria: February 25, 2024
• First Posted (Estimated): March 4, 2024

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 25, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Acute Ischemic Stroke; Endovascular Thrombectomy; MCE; sICH
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Hemorrhage; Intracranial Hemorrhages; Brain Edema
• Other Study ID Numbers: IAT-PROACT

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