Status:
COMPLETED
PROMISE: PRedictors Of Good outcoMes in Thrombectomy for Large Infarct Core Stroke Evaluation
Lead Sponsor:
115 People's Hospital
Collaborating Sponsors:
University of Medicine and Pharmacy at Ho Chi Minh City
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18+ years
Brief Summary
Identify the factors associated with a favorable clinical outcome in participants with acute ischemic stroke and large core infarcts within 24 hours of onset who are treated with endovascular interven...
Detailed Description
In 2022 and early 2023, three randomized controlled trials-RESCUE-JAPAN LIMIT, SELECT 2, and ANGEL ASPECT-were published in the New England Journal of Medicine. These trials demonstrated the effective...
Eligibility Criteria
Inclusion
- Age ≥ 18-year-old
- Patients presenting with acute ischaemic stroke within 24 hours of stroke onset
- Received mechanical thrombectomy within 24 hours of stroke onset
- Imaging criteria include:
- Large vessel occlusion on CT Angiography or MR Angiography (MRA) including tandem occlusion of the internal carotid artery and middle cerebral artery or internal carotid artery.
- Core infarct criteria:
- ASPECTS ≤5 on non-contrast CT or diffusion-weighted imaging (DWI).
- ASPECTS score \>5 and core infarct volume of 50-150 ml on CT perfusion (CTP) or reduced cerebral blood flow (rCBF) \<30% on CTP or apparent diffusion coefficient (ADC) \<620 × 10-6 mm2/s on DWI.
Exclusion
- Patients presenting with acute ischaemic stroke \>24 hours of stroke onset
- Intracranial hemorrhage identified by CT or MRI
- Pre-stroke modified Rankin Score (mRS) score of \>2 (indicating previous disability)
- Any terminal illness such that the patient has a life expectancy of less than 1 year.
- Patients with active cancer and undergoing treatment for cancer are excluded,
- Pregnancy
Key Trial Info
Start Date :
July 28 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 26 2025
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06016348
Start Date
July 28 2023
End Date
August 26 2025
Last Update
September 2 2025
Active Locations (4)
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1
Can Tho Central General Hospital
Can Tho, Vietnam
2
Da Nang Stroke Center
Da Nang, Vietnam
3
115 PEOPLE's HOSPITAL
Ho Chi Minh City, Vietnam, 70000
4
University Medical Center
Ho Chi Minh City, Vietnam, 70000