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NCT Number: NCT05230914

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

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.

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Key information

Conditions

Stroke, Ischemic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Stroke, Acute Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yijishan Hospital of Wannan Medical College, Wuhu, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Simplified imaging strategy

Other

NCCT and CTA will be used to screen patients for endovascular treatment

Standard imaging strategy

Other

NCCT-ASPECTS (pc-ASPECTS), CTA, and CTP will be used to screen patients for endovascular treatment

Primary outcomes

  1. favorable outcome at 90 days

    Time frame: 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 outcomes

  1. symptomatic intracranial hemorrhage within 48 hours

    Time frame: within 48 hours post-endovascular treatment

    symptomatic intracranial hemorrhage according to Heidelberg criteria

  2. mortality at 90 days

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Xinqiao Hospital of Chongqing

Other

Collaborators

  • Dalian Central Hospital
  • Huai'an First People's Hospital
  • The First Affiliated Hospital of Hainan Medical University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 9, 2022
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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