Clinical trial NCT05230914: A Randomized Trial of Imaging Selection Modalities for Stroke Thrombectomy (NO-SELECT)
Official title: Simple Imaging Versus Standard Imaging Selection in Stroke Patients for Endovascular Treatment: the NO-SELECT Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke, Ischemic
Stroke, Acute
Keywords: endovascular treatment
large vessel occlusion
acute ischemic stroke
computed tomography perfusion
non-contrast computed tomography
Alberta Stroke Program Early CT score
Lead sponsor: Xinqiao Hospital of Chongqing
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Hainan Medical University
name: Dalian Central Hospital
name: Huai'an First People's Hospital
First posted: 2022-02-09
Enrollment: 1846
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Aged 18 years or older;
2. The interval time from last known well to hospital arrival is within 24 hours;
3. Acute stroke confirmed by clinical symptoms or imaging examination;
4. Field Assessment Stroke Triage for Emergency Destination (FAST ED) ≥4;
5. Written informed consent is obtained from patients and/or their legal representatives.

Exclusion Criteria:

1. Allergy to radiographic contrast agents, or nitinol devices;
2. Currently pregnant or lactating (women patients);
3. Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel;
4. Preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
5. Multiple vessel occlusion (e.g., bilateral anterior circulation, or occlusion of both anterior and posterior circulation);
6. Brain tumors with mass effect (except meningiomas) that are radiographically pleasant;
7. Intracranial aneurysm, arteriovenous malformation;
8. Any terminal illness with life expectancy less than 6 months;
9. Unlikely to be available for 90-day follow-up.

Primary outcomes:
measure: favorable outcome at 90 days
timeFrame: 90 days post-endovascular treatment
Secondary outcomes:
measure: symptomatic intracranial hemorrhage within 48 hours
timeFrame: within 48 hours post-endovascular treatment
measure: mortality at 90 days
timeFrame: 90 days post-endovascular treatment
Other outcomes:
Locations:
city: Wuhu
country: China
facility: Yijishan Hospital of Wannan Medical College
state: Anhui
city: Chongqing
country: China
facility: Xinqiao Hospital of Army Medical University
state: Chongqing
city: Jiangmen
country: China
facility: Wuyi Traditional Chinese Medicine Hospital
state: Guangdong
city: Jiangmen
country: China
facility: Jiangmen Central Hospital
state: Guangdong
city: Maoming
country: China
facility: Maoming Traditional Chinese Medicine Hospital
state: Guangdong
city: Guilin
country: China
facility: The 924th Hospital of CPLA
state: Guangxi
city: Haikou
country: China
facility: The First Affiliated Hospital of Hainan Medical University
state: Hainan
city: Wuhan
country: China
facility: Wuhan No. 1 Hospital
state: Hubei
city: Huai'an
country: China
facility: Huai'an First People's Hospital
state: Jiangsu
city: Wuxi
country: China
facility: The 904th Hospital of CPLA
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
city: Jingdezhen
country: China
facility: Jingdezhen First People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: The First Affiliated Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: Dalian Central Hospital
state: Liaoning
city: Luzhou
country: China
facility: The Affiliated Hospital of Southwest Medical University
state: Sichuan
Study officials:
References: