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

Stroke, Acute Clinical Trial

Official title:

Simple Imaging Versus Standard Imaging Selection in Stroke Patients for Endovascular Treatment: the NO-SELECT Cluster-randomized, Crossover Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05230914
• Other study ID #: NO-SELECT
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: December 2023
• Source: Xinqiao Hospital of Chongqing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 7000
• Est. completion date: June 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Aged 18 years or older

2. Presenting with acute ischemic stroke within 24 hours from last known well to randomization

3. Baseline NIHSS score >6 points

4. Planned treatment with endovascular treatment by clinical care team

5. Informed consent obtained from patients or their legal representatives

6. CT or MR excludes hemorrhage

7. Occlusion of the intracranial internal carotid artery, the first or second segment of the middle cerebral artery (MCA-M1 or -M2), or vertebrobasilar artery confirmed by CTA/MRA/DSA

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.

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke
• Stroke, Acute
• Stroke, Ischemic

Intervention

Other:
• Simplified imaging strategy
NCCT and CTA will be used to screen patients for endovascular treatment
• Standard imaging strategy
NCCT-ASPECTS (pc-ASPECTS), CTA, and CTP will be used to screen patients for endovascular treatment

Locations

Country	Name	City	State
China	Banan District People's Hospital	Banan	Chongqing
China	The First Affiliated Hospital of Jilin University	Changchun	Jilin
China	Xinqiao Hospital of Army Medical University	Chongqing	Chongqing
China	Danzhai People's Hospital	Danzhai	Guizhou
China	The 924th Hospital of CPLA	Guilin	Guangxi
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	Jiangmen Central Hospital	Jiangmen	Guangdong
China	Wuyi Traditional Chinese Medicine Hospital	Jiangmen	Guangdong
China	The Affiliated Hospital of Southwest Medical University	Luzhou	Sichuan
China	Maoming Traditional Chinese Medicine Hospital	Maoming	Guangdong
China	Nanyang Central Hospital	Nanyang	Henan
China	Wuhan No. 1 Hospital	Wuhan	Hubei
China	Yijishan Hospital of Wannan Medical College	Wuhu	Anhui
China	The 904th Hospital of CPLA	Wuxi	Jiangsu
China	Xuzhou Central Hospital	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Xinqiao Hospital of Chongqing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	symptomatic intracranial hemorrhage within 48 hours	symptomatic intracranial hemorrhage according to Heidelberg criteria	within 48 hours post-endovascular treatment
Secondary	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