Stroke, IschemicNCT05230914
A Randomized Trial of Imaging Selection Modalities for Stroke Thrombectomy (NO-SELECT)
A study testing Simplified imaging strategy and Standard imaging strategy in people with Stroke, Ischemic and Stroke, Acute, run by Xinqiao Hospital of Chongqing at 8 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic, Stroke, Acute
- What is being tested?
- Simplified imaging strategy and Standard imaging strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,846 participants
- Where
- 8 sitesChina
- Study dates
- 12 Dec 2024to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- Intracranial aneurysm, arteriovenous malformation;
- Any terminal illness with life expectancy less than 6 months;
- Unlikely to be available for 90-day follow-up.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites, 8 recruiting
- Not yet recruiting
Xinqiao Hospital of Army Medical University
Chongqing, Chongqing Municipality, 400037
Zhongming Qiu, MD, 13236599269, qiuzhongmingdoctor@163.com
- Recruiting
Dalian Central Hospital
Dalian, Liaoning, 116000
Zhongjun Chen, MD, 18841180447, chenjiajin1983729@163.com
- Recruiting
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570000
Zhenqiang Zhao, MD, 13976015677, zhenqiang.zhao@qq.com
- Recruiting
Huai'an First People's Hospital
Huai'an, Jiangsu, 223001
Mingchao Li, MS, 13915105260, shuyanglmc@163.com
- Not yet recruiting
Wuyi Traditional Chinese Medicine Hospital
Jiangmen, Guangdong, 529000
Tao Yu, MD, 13631896333
- Recruiting
Jingdezhen First People's Hospital
Jingdezhen, Jiangxi, 333000
Shunfu Jiang, MS, 18907982686, 869shenli@163.com
- Recruiting
Yijishan Hospital of Wannan Medical College
Wuhu, Anhui, 241000
Zhiming Zhou, MD, 13966019211, neuro_depar@hotmail.com
- Not yet recruiting
The 904th Hospital of CPLA
Wuxi, Jiangsu, 214000
Zhonghua Shi, MD, +8618921150310, 18921150310@189.cn
About this study
Official title: 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.
- Conditions
- Stroke, Ischemic, Stroke, Acute
- Being tested
- Simplified imaging strategy, Standard imaging strategy
- Keywords
- endovascular treatment, large vessel occlusion, acute ischemic stroke, computed tomography perfusion, non-contrast computed tomography, Alberta Stroke Program Early CT score
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simplified imaging strategyOther
NCCT and CTA will be used to screen patients for endovascular treatment
Standard imaging strategyOther
NCCT-ASPECTS (pc-ASPECTS), CTA, and CTP will be used to screen patients for endovascular treatment
| Study group | Role | What they receive |
|---|---|---|
| Simple imaging | Experimental | NCCT and CTA will be used to screen patients for endovascular treatment Receives: Other: Simplified imaging strategy |
| Standard imaging | Active comparator | NCCT-ASPECTS (pc-ASPECTS), CTA, and CTP will be used to screen patients for endovascular treatment Receives: Other: Standard imaging strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days post-endovascular treatment
Secondary outcomes (2)
symptomatic intracranial hemorrhage within 48 hours
symptomatic intracranial hemorrhage according to Heidelberg criteria
Measured: 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
Measured: 90 days post-endovascular treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start12 Dec 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1,846 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Hainan Medical University, Dalian Central Hospital, Huai'an First People's Hospital
- Responsible party
- Principal investigator, Zhongming Qiu, Xinqiao Hospital of Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230914
- Sponsor's protocol ID
- NO-SELECT
- Status last verified
- Dec 2025
- First submitted
- 27 Jan 2022
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study data without patient information
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simple Imaging Versus Standard Imaging Selection in Stroke Patients for Endovascular Treatment: the NO-SELECT Randomized Trial
- ClinicalTrials.gov ID
- NCT05230914
- Acronym / sponsor ID
- NO-SELECT
- Conditions
- Stroke, Ischemic, Stroke, Acute
- Keywords
- endovascular treatment, large vessel occlusion, acute ischemic stroke, computed tomography perfusion, non-contrast computed tomography, Alberta Stroke Program Early CT score
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,846 participants (estimated)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Hainan Medical University, Dalian Central Hospital, Huai'an First People's Hospital
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simple imaging | Experimental | Other: Simplified imaging strategyNCCT and CTA will be used to screen patients for endovascular treatment |
| Standard imaging | Active comparator | Other: Standard imaging strategyNCCT-ASPECTS (pc-ASPECTS), CTA, and CTP will be used to screen patients for endovascular treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simplified imaging strategyNCCT and CTA will be used to screen patients for endovascular treatment | Other | Simple imaging |
| Standard imaging strategyNCCT-ASPECTS (pc-ASPECTS), CTA, and CTP will be used to screen patients for endovascular treatment | Other | Standard imaging |
Primary outcome
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.
2 secondary outcomes
symptomatic intracranial hemorrhage within 48 hours
Time frame: within 48 hours post-endovascular treatment
mortality at 90 days
Time frame: 90 days post-endovascular treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: Yes. study data without patient information
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simplified imaging strategy and Standard imaging strategy in people with Stroke, Ischemic and Stroke, Acute, run by Xinqiao Hospital of Chongqing at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
favorable outcome at 90 days (time frame: 90 days post-endovascular treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.