Endovascular Treatment for Patients with Extreme Large Core Infarct Stroke: A Multi-center, Prospective, Open-label, Blind-endpoint Randomized Control Trial.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500109971

Enrollment

Unknown

Registered

2025-09-28

Start date

2025-11-07

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke

Interventions

Trial group:Endovascular Treatment Plus Standard Drug Therapy (Endovascular Treatment Group). Patients undergo endovascular procedures such as thrombectomy or aspiration combined with standard drug th

Control group:Standard Drug Therapy Group (Control Group). Patients receive standard drug therapy.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years; 2. Time from stroke onset or last known well to hospital arrival =100 mL (core defined as relative cerebral blood flow rCBF <30%); 5. Patient or legal guardian has signed the written informed consent.

Exclusion criteria

Exclusion criteria: 1. Intracranial hemorrhage confirmed by cranial computed tomography (CT) or magnetic resonance imaging (MRI); 2. Pre-onset modified Rankin Scale (mRS) score >= 2; 3. Pregnant or breastfeeding women; 4. Genetic or acquired bleeding disorders, deficiency of anticoagulant factors; or current use of anticoagulants with an INR >3; 5. Intracranial tumors with mass effect on imaging (excluding small meningiomas); 6. End-stage disease with an expected survival of less than 6 months; 7. Expected inability to complete follow-up; 8. Brain herniation causing midline shift of the brain; 9. Presence of severe comorbidities potentially affecting prognosis and follow-up (e.g., cancer, severe heart failure, renal failure); 10. Suspected septic embolism or bacterial endocarditis; 11. Currently participating in other clinical trials.

Design outcomes

Primary

Measure	Time frame
mRS score 0-3 at 90d (%);mortality at 90d (%);Incidence of symptomatic intracranial hemorrhage (SICH) within 48h;	—

Secondary

Measure	Time frame
mRS score 0-1 at 90d(%);mRS score 0-2 at 90d(%);90d mRS score improvement;90d mRS score 0-4 (%);90-day EQ-5D scale score;Incidence of any intracranial hemorrhage within 48 hours(48h anyICH);7-Day Mortality Rate;	—

Countries

China

Contacts

Public ContactZheng Peng

The First Affiliated Hospital of Chongqing Medical University

282971157@qq.com+86 185 8101 0769

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026