A Randomized Trial of Imaging Selection Modalities for Stroke Thrombectomy (NO-SELECT)

Xinqiao Hospital of Chongqing1,846 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

1,846

Conditions

Stroke, Ischemic Stroke, Acute

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (8)

Yijishan Hospital of Wannan Medical College

Wuhu, Anhui, China

RECRUITING

Xinqiao Hospital of Army Medical University

Chongqing, Chongqing Municipality, China

NOT_YET_RECRUITING

Wuyi Traditional Chinese Medicine Hospital

Jiangmen, Guangdong, China

NOT_YET_RECRUITING

The First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

RECRUITING

Huai'an First People's Hospital

Huai'an, Jiangsu, China

RECRUITING

The 904th Hospital of CPLA

Wuxi, Jiangsu, China

NOT_YET_RECRUITING

Jingdezhen First People's Hospital

Jingdezhen, Jiangxi, China

RECRUITING

Dalian Central Hospital

Dalian, Liaoning, China

RECRUITING

Outcomes

Primary Outcomes

favorable outcome at 90 days

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.

Time frame: 90 days post-endovascular treatment

Secondary Outcomes

symptomatic intracranial hemorrhage within 48 hours

symptomatic intracranial hemorrhage according to Heidelberg criteria

Time frame: within 48 hours post-endovascular treatment

mortality at 90 days

defined as the number of deaths observed divided by the number of subjects observed over the 90-day study period

Time frame: 90 days post-endovascular treatment