NCT05230914 A Randomized Trial of Imaging Selection Modalities for Stroke Thrombectomy (NO-SELECT)
| NCT ID | NCT05230914 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xinqiao Hospital of Chongqing |
| Condition | Stroke, Ischemic |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,846 participants |
| Start Date | 2024-12-12 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,846 participants in total. It began in 2024-12-12 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Frequently Asked Questions
Who can join the NCT05230914 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke, Ischemic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05230914 currently recruiting?
Yes, NCT05230914 is actively recruiting participants. Visit ClinicalTrials.gov or contact Xinqiao Hospital of Chongqing to inquire about joining.
Where is the NCT05230914 trial being conducted?
This trial is being conducted at Wuhu, China, Chongqing, China, Jiangmen, China, Haikou, China and 4 additional locations.
Who is sponsoring the NCT05230914 clinical trial?
NCT05230914 is sponsored by Xinqiao Hospital of Chongqing. The trial plans to enroll 1,846 participants.
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