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

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

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 Overview

• Status: Recruiting
• Conditions: Stroke, Ischemic; Stroke, Acute
• Intervention / Treatment: Other: Simplified imaging strategy; Other: Standard imaging strategy

• Study Type: Interventional
• Enrollment (Estimated): 1846
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui
    • Wuhu, Anhui, China, 241000
      • Recruiting
      • Yijishan Hospital of Wannan Medical College
      • Contact: Zhiming Zhou, MD; Phone Number: 13966019211; Email: neuro_depar@hotmail.com
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400037
      • Not yet recruiting
      • Xinqiao Hospital of Army Medical University
      • Contact: Zhongming Qiu, MD; Phone Number: 13236599269; Email: qiuzhongmingdoctor@163.com
  • Guangdong
    • Jiangmen, Guangdong, China, 529000
      • Not yet recruiting
      • Wuyi Traditional Chinese Medicine Hospital
      • Contact: Tao Yu, MD; Phone Number: 13631896333
  • Hainan
    • Haikou, Hainan, China, 570000
      • Recruiting
      • The First Affiliated Hospital of Hainan Medical University
      • Contact: Zhenqiang Zhao, MD; Phone Number: 13976015677; Email: zhenqiang.zhao@qq.com
  • Jiangsu
    • Huai'an, Jiangsu, China, 223001
      • Recruiting
      • Huai'an first people's hospital
      • Contact: Mingchao Li, MS; Phone Number: 13915105260; Email: shuyanglmc@163.com
    • Wuxi, Jiangsu, China, 214000
      • Not yet recruiting
      • The 904th Hospital of CPLA
      • Contact: Zhonghua Shi, MD; Phone Number: +8618921150310; Email: 18921150310@189.cn
  • Jiangxi
    • Jingdezhen, Jiangxi, China, 333000
      • Recruiting
      • Jingdezhen First People's Hospital
      • Contact: Shunfu Jiang, MS; Phone Number: 18907982686; Email: 869shenli@163.com
  • Liaoning
    • Dalian, Liaoning, China, 116000
      • Recruiting
      • Dalian Central Hospital
      • Contact: Zhongjun Chen, MD; Phone Number: 18841180447; Email: chenjiajin1983729@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Simple imaging; NCCT and CTA will be used to screen patients for endovascular treatment	Other: Simplified imaging strategy; NCCT and CTA will be used to screen patients for endovascular treatment
Active Comparator: Standard imaging; NCCT-ASPECTS (pc-ASPECTS), CTA, and CTP will be used to screen patients for endovascular treatment	Other: Standard imaging strategy; NCCT-ASPECTS (pc-ASPECTS), CTA, and CTP will be used to screen patients for endovascular treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90 days post-endovascular treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
symptomatic intracranial hemorrhage within 48 hours	symptomatic intracranial hemorrhage according to Heidelberg criteria	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	90 days post-endovascular treatment

Collaborators and Investigators

• Sponsor: Xinqiao Hospital of Chongqing
• Collaborators: Huai'an First People's Hospital; The First Affiliated Hospital of Hainan Medical University; Dalian Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: January 27, 2022
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): February 9, 2022

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: endovascular treatment; acute ischemic stroke; large vessel occlusion; computed tomography perfusion; non-contrast computed tomography; Alberta Stroke Program Early CT score
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Ischemic Stroke; Stroke
• Other Study ID Numbers: NO-SELECT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: study data without patient information
• IPD Sharing Time Frame: Related papers published 6 months later, the IPD will be shared
• IPD Sharing Access Criteria: yangqwmlys@163.com
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No