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

NCT ID: NCT05230914

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1846 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2027-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke, Ischemic Stroke, Acute

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Simple imaging

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

Group Type EXPERIMENTAL

Simplified imaging strategy

Intervention Type OTHER

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

Standard imaging

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

Group Type ACTIVE_COMPARATOR

Standard imaging strategy

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Simplified imaging strategy

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

Intervention Type OTHER

Standard imaging strategy

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The First Affiliated Hospital of Hainan Medical University

OTHER_GOV

Sponsor Role collaborator

Dalian Central Hospital

UNKNOWN

Sponsor Role collaborator

Huai'an First People's Hospital

OTHER

Sponsor Role collaborator

Xinqiao Hospital of Chongqing

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zhongming Qiu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Yijishan Hospital of Wannan Medical College

Wuhu, Anhui, China

Site Status

Xinqiao Hospital of Army Medical University

Chongqing, Chongqing Municipality, China

Site Status

Wuyi Traditional Chinese Medicine Hospital

Jiangmen, Guangdong, China

Site Status

Jiangmen Central Hospital

Jiangmen, Guangdong, China

Site Status

Maoming Traditional Chinese Medicine Hospital

Maoming, Guangdong, China

Site Status

The 924th Hospital of CPLA

Guilin, Guangxi, China

Site Status

The First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

Site Status

Wuhan No. 1 Hospital

Wuhan, Hubei, China

Site Status

Huai'an First People's Hospital

Huai'an, Jiangsu, China

Site Status

The 904th Hospital of CPLA

Wuxi, Jiangsu, China

Site Status

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Site Status

Jingdezhen First People's Hospital

Jingdezhen, Jiangxi, China

Site Status

The First Affiliated Hospital of Jilin University

Changchun, Jilin, China

Site Status

Dalian Central Hospital

Dalian, Liaoning, China

Site Status

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Zhenqiang Zhao, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NO-SELECT

Identifier Type: -

Identifier Source: org_study_id