Simple non-contrast CT versus advanced imaging to choose thrombectomy for acute large-vessel stroke

Simple Imaging Versus Standard Imaging Selection in Stroke Patients for Endovascular Treatment: the NO-SELECT Randomized Trial

This trial tests whether a simple non-contrast CT scan (using ASPECTS) works as well as advanced imaging (CT perfusion or MRI) to decide if people with acute large-vessel ischemic stroke should have thrombectomy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1846 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Xinqiao Hospital of Chongqing (other)
• Locations: 8 sites (Wuhu, Anhui and 7 other locations)
• Trial ID: NCT05230914 on ClinicalTrials.gov

What this trial studies

This randomized trial enrolls adults with anterior large-vessel occlusion stroke who arrive within 24 hours and randomizes them to a simplified imaging selection strategy (non-contrast CT/ASPECTS) or a standard imaging strategy (CT perfusion or MRI) to determine eligibility for endovascular thrombectomy. The primary aim is to see if outcomes after thrombectomy selected by simple imaging are non-inferior to those selected by advanced imaging. Key inclusion criteria include age ≥18, FAST-ED ≥4, and arrival within 24 hours of last known well, while key exclusions include multiple vessel occlusion, arterial tortuosity preventing device access, certain intracranial vascular lesions, pregnancy, and contrast allergy. The trial is being conducted at several hospitals in China and compares clinical and imaging endpoints between the two selection pathways.

Who should consider this trial

Good fit: Adults (≥18) with acute anterior large-vessel occlusion stroke who present within 24 hours, have a FAST-ED score ≥4, and can provide informed consent are the intended participants.

Not a fit: Patients with multiple vessel occlusions, significant arterial tortuosity that prevents device access, intracranial aneurysms or arteriovenous malformations, contrast allergy, pregnancy, or preexisting neurological/psychiatric conditions that confound outcome measurement are unlikely to benefit from this selection approach.

Why it matters

Potential benefit: If successful, using simple non-contrast CT could allow more patients to be rapidly identified and treated with thrombectomy without needing advanced perfusion imaging.

How similar studies have performed: Recent trials such as MR CLEAN-LATE and TENSION used NCCT/CTA with ASPECTS for selection and supported endovascular therapy in extended windows, but a direct randomized non-inferiority comparison of NCCT versus advanced perfusion imaging remains limited.

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.

Where this trial is running

Wuhu, Anhui and 7 other locations

• 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)

Conditions: Stroke, Ischemic, Stroke, Acute, endovascular treatment, large vessel occlusion, acute ischemic stroke, computed tomography perfusion, non-contrast computed tomography, Alberta Stroke Program Early CT score