A Randomized Trial of Imaging Selection Modalities for Stroke Thrombectomy (NO-SELECT)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorXinqiao Hospital of Chongqing
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Simplified imaging strategy
Other interventionNCCT and CTA will be used to screen patients for endovascular treatment
Standard imaging strategy
Other interventionNCCT-ASPECTS (pc-ASPECTS), CTA, and CTP will be used to screen patients for endovascular treatment
Treatment groups
1,846 Participants
are divided into 2 treatment groupsGroup A: Simple imagingExperimental treatment 1 intervention
Group B: Standard imagingActive comparator 1 intervention
Trial outcomes
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.
Time frame
90 days post-endovascular treatmentSecondary outcomes
1
symptomatic intracranial hemorrhage within 48 hours
symptomatic intracranial hemorrhage according to Heidelberg criteria
Time frame
within 48 hours post-endovascular treatment2
mortality at 90 days
defined as the number of deaths observed divided by the number of subjects observed over the 90-day study period
Time frame
90 days post-endovascular treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Xinqiao Hospital of Chongqing
Lead sponsor
The First Affiliated Hospital of Hainan Medical University
Collaborator
Dalian Central Hospital
Collaborator
Huai'an First People's Hospital
Collaborator
Source ClinicalTrials.gov