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

NCT06290076 | Completed

• 1 other identifier: IAT-PROACT
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Ischemic Stroke; Endovascular Thrombectomy; Symptomatic Intracranial Hemorrhage; Malignant Cerebral Edema

Keywords

Acute Ischemic Stroke; Endovascular Thrombectomy; sICH; MCE

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Rate of mRS score of 3-6

  90 days (±7 days) after thrombectomy

• Rate of mRS score of 5-6

  90 days (±7 days) after thrombectomy

• Rate of symptomatic intracranial hemorrhage

  Within 72 hours after thrombectomy

• Rate of malignant cerebral edema

  Within 72 hours after thrombectomy

• Change of NIHSS score

  24-72 hours after thrombectomy versus admission

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Related Publications (1)

• 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.

  PMID: 41130675 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: March 4, 2024
• Study Start: January 1, 2020
• Primary Completion: June 30, 2023
• Study Completion: September 30, 2023
• Last Updated: March 4, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)