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

Not Applicable

Not yet recruiting

• Conditions: Stroke, Acute; Stroke, Ischemic

• Registration Number: NCT05230914
• Lead Sponsor: Xinqiao Hospital of Chongqing

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-27
• Study First Submitted QC: 2022-01-27
• Study First Posted: 2022-02-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-20
• Study Start: 2025-01-01
• Primary Completion: 2027-01-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1846

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
favorable outcome at 90 days	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 Outcome Measures

Name	Time	Method
mortality at 90 days	90 days post-endovascular treatment	defined as the number of deaths observed divided by the number of subjects observed over the 90-day study period
symptomatic intracranial hemorrhage within 48 hours	within 48 hours post-endovascular treatment	symptomatic intracranial hemorrhage according to Heidelberg criteria

Trial Locations

Locations (15)

The First Affiliated Hospital of Hainan Medical University; 🇨🇳 Haikou, Hainan, China

Huai'an First People's Hospital; 🇨🇳 Huai'an, Jiangsu, China

Jingdezhen First People's Hospital; 🇨🇳 Jingdezhen, Jiangxi, China

Dalian Central Hospital; 🇨🇳 Dalian, Liaoning, China

Yijishan Hospital of Wannan Medical College; 🇨🇳 Wuhu, Anhui, China

Xinqiao Hospital of Army Medical University; 🇨🇳 Chongqing, Chongqing, China

Wuyi Traditional Chinese Medicine Hospital; 🇨🇳 Jiangmen, Guangdong, China

Jiangmen Central Hospital; 🇨🇳 Jiangmen, Guangdong, China

Maoming Traditional Chinese Medicine Hospital; 🇨🇳 Maoming, Guangdong, China

The 924th Hospital of CPLA; 🇨🇳 Guilin, Guangxi, China

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