Clinical trial NCT06290076: A Predictive Model and Scoring System for Severe Complications After Endovascular Thrombectomy
Official title: A Predictive Model and Scoring System for Severe Complications After Endovascular Thrombectomy: a Retrospective, Multicenter, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Ischemic Stroke
Endovascular Thrombectomy
Symptomatic Intracranial Hemorrhage
Malignant Cerebral Edema
Keywords: Acute Ischemic Stroke
Endovascular Thrombectomy
sICH
MCE
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of severe complications
timeFrame: Within 72 hours after thrombectomy
Secondary outcomes:
measure: Rate of mRS score of 3-6
timeFrame: 90 days (±7 days) after thrombectomy
measure: Rate of mRS score of 5-6
timeFrame: 90 days (±7 days) after thrombectomy
measure: Rate of symptomatic intracranial hemorrhage
timeFrame: Within 72 hours after thrombectomy
measure: Rate of malignant cerebral edema
timeFrame: Within 72 hours after thrombectomy
measure: Change of NIHSS score
timeFrame: 24-72 hours after thrombectomy versus admission
measure: Rate of modified Rankin Scale (mRS) score of 0-2
timeFrame: 90 days (±7 days) after thrombectomy
measure: All-cause mortality
timeFrame: 90 days (±7 days) after thrombectomy
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
Study officials:
References: