Simple Imaging Versus Standard Imaging Selection in Stroke Patients for Endovascular Treatment: the NO-SELECT Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,846
- Locations
- 8
- Primary Endpoint
- favorable outcome at 90 days
Study Overview
Brief Summary
Several studies suggest that advanced multi-modal imaging with CTP should be used to screen late time window stroke patients for thrombectomy. However, NCCT is more accessible when comparing with CTP. It is unclear whether the NCCT-based ASPECTS can be used as an imaging criterion to screen patients for thrombectomy.
The newly published MR CLEAN-LATE and TENSION trials used NCCT or CTA, but still relied on ASPECTS scores to evaluate and select patients for endovascular therapy. However, different trials have different time windows. The aim of this trial was to assess the clinical outcomes of stroke patients with anterior large vessel occlusion who selected by simple imaging (NCCT) comparing via standard imaging screening strategy (CTP/MRI). The hypothesis is that simple imaging is non-inferior to standard imaging selection strategy in terms of achieving favorable outcomes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 18 years or older;
- •The interval time from last known well to hospital arrival is within 24 hours;
- •Acute stroke confirmed by clinical symptoms or imaging examination;
- •Field Assessment Stroke Triage for Emergency Destination (FAST ED) ≥4;
- •Written informed consent is obtained from patients and/or their legal representatives.
Exclusion Criteria
- •Allergy to radiographic contrast agents, or nitinol devices;
- •Currently pregnant or lactating (women patients);
- •Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel;
- •Preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
- •Multiple vessel occlusion (e.g., bilateral anterior circulation, or occlusion of both anterior and posterior circulation);
- •Brain tumors with mass effect (except meningiomas) that are radiographically pleasant;
- •Intracranial aneurysm, arteriovenous malformation;
- •Any terminal illness with life expectancy less than 6 months;
- •Unlikely to be available for 90-day follow-up.
Outcomes
Primary Outcomes
favorable outcome at 90 days
Time Frame: 90 days post-endovascular treatment
defined as modified Rankin scale score of 0 to 3. Modified Rankin scale score (mRS): scores range from 0 to 6, with 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death.
Secondary Outcomes
- mortality at 90 days(90 days post-endovascular treatment)
- symptomatic intracranial hemorrhage within 48 hours(within 48 hours post-endovascular treatment)
Investigators
Zhongming Qiu
Professor
Xinqiao Hospital of Chongqing