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

Acute Ischemic Stroke Clinical Trial

Official title:

A Predictive Model and Scoring System for Severe Complications After Endovascular Thrombectomy: a Retrospective, Multicenter, Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06290076
• Other study ID #: IAT-PROACT
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: September 30, 2023

Study information

• Verified date: February 2024
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: September 30, 2023
• Est. primary completion date: June 30, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Brain Edema
• Endovascular Thrombectomy
• Hemorrhage
• Intracranial Hemorrhages
• Ischemic Stroke

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of mRS score of 3-6	The mRS score range from 0 (no disability) to 6 (death)	90 days (±7 days) after thrombectomy
Secondary	Rate of mRS score of 5-6	The mRS score range from 0 (no disability) to 6 (death)	90 days (±7 days) after thrombectomy
Secondary	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
Secondary	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
Secondary	Change of NIHSS score	The NIHSS score range from 0 (no deficit) to 42 (maximum deficit)	24-72 hours after thrombectomy versus admission
Secondary	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
Secondary	All-cause mortality	Death defined as a mRS score of 6	90 days (±7 days) after thrombectomy