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

NCT05230914 | Recruiting DMC

• 1 other identifier: NO-SELECT
• Study Type: interventional
• Target: 1,846
• Locations: 1 country
• Sites: 8

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• symptomatic intracranial hemorrhage within 48 hours

  within 48 hours post-endovascular treatment

• mortality at 90 days

  90 days post-endovascular treatment

Study Arms (2)

Simple imaging

EXPERIMENTAL

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

Other: Simplified imaging strategy

Standard imaging

ACTIVE COMPARATOR

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

Other: Standard imaging strategy

Interventions

Simplified imaging strategy OTHER

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

Simple imaging

Standard imaging strategy OTHER

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

Standard imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinqiao Hospital of Chongqing: lead
• The First Affiliated Hospital of Hainan Medical University: collaborator
• Dalian Central Hospital: collaborator
• Huai'an First People's Hospital: collaborator

Study Sites (8)

Yijishan Hospital of Wannan Medical College

Wuhu, Anhui, 241000, China

RECRUITING

Xinqiao Hospital of Army Medical University

Chongqing, Chongqing Municipality, 400037, China

NOT YET RECRUITING

Wuyi Traditional Chinese Medicine Hospital

Jiangmen, Guangdong, 529000, China

NOT YET RECRUITING

The First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, 570000, China

RECRUITING

Huai'an First People's Hospital

Huai'an, Jiangsu, 223001, China

RECRUITING

The 904th Hospital of CPLA

Wuxi, Jiangsu, 214000, China

NOT YET RECRUITING

Jingdezhen First People's Hospital

Jingdezhen, Jiangxi, 333000, China

RECRUITING

Dalian Central Hospital

Dalian, Liaoning, 116000, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 9, 2022
• Study Start: December 12, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Related papers published 6 months later, the IPD will be shared
• Access Criteria: yangqwmlys@163.com

Locations

CN (8)