Clinical trial NCT05311605: REperfusion Therapy for Acute Ischemic STrOke Due to Large aRtEry Occlusion
Official title: REperfusion Therapy for Acute Ischemic STrOke Due to Large aRtEry Occlusion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Vascular Occlusion
Endovascular Treatment
Mechanical Thrombectomy
Perfusion Imaging
Keywords: ischemic stroke
vascular occlusion
endovascular treatment
mechanical thrombectomy
perfusion imaging
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
name: Beijing Municipal Science & Technology Commission
name: Beijing Municipal Administration of Hospitals
First posted: 2022-04-05
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ischemic stroke patients that received mechanical thrombectomy due to large vessel occlusion of anterior circulation within 24 hours from stroke onset and had perfusion imaging both before and after thrombectomy.

Brief summary: The aim of the study was to establish a clinical and advanced imaging database of acute ischemic stroke patients treated with mechanical thrombectomy due to large vessel occlusion of anterior circulation within 24 hours from stroke onset in China, and to investigate the predictors and potential mechanisms of futile recanalization after mechanical thrombectomy.

Detailed description: The time-window of mechanical thrombectomy for ischemic stroke has extended from 4.5 hours to 24 hours based on the results of the DAWN and DEFUSE 3 trials. However, evidence on the effectiveness and safety of mechanical thrombectomy within 24 hours in the real-world is insufficient.

This is a multi-center, prospective, registry cohort study that acute ischemic stroke patients treated with mechanical thrombectomy due to large vessel occlusion of anterior circulation within 24 hours from stroke onset in China. A retrospective dataset was also build in these stroke centers for analysis. A total of 1600 patients with advanced imaging data were anticipated to be enrolled.

Eligibility criteria: Inclusion Criteria:

* Older than 18 years;
* Perfusion imaging completed including CTA+CTP or MRA+PWI+DWI before thrombectomy
* Large vessel occlusion of cerebral anterior circulation (ICA, MCA-M1 or MCA-M2) confirmed by CTA or MRA, planned to receive or received stenting or aspiration thrombectomy
* Time intervals ≤ 24 hours from stroke onset to groin puncture.(fulfilled the inclusion of DAWN or DEFUSE 3 trial if the time intervals from stroke onset to groin puncture was ≥6 hours)
* mRS score ≤2 before admission
* Informed consent obtained for longitudinal enrolled patients, waived of consent for retrospectively included cases

Exclusion Criteria:

* Had a history of infective disease, immunity disease, radiotherapy at head or neck, carotid dissection or other carotid disease.
* Unable to receive CT or MR scan due to heart failure, cardiac pacemaker, metal implants or claustrophobia, etc.
* Unable to be injected with contrast agent due to allergy, renal dysfunction, etc.
* Unlikely to adhere to the study protocol or follow-up ( life expectancy ≤ 3 months)
* Already participated in other drug trials

Primary outcomes:
measure: Favorable functional outcome
timeFrame: 3 months from stroke onset
Secondary outcomes:
measure: Excellent functional outcome at 90 days
timeFrame: 3 months from stroke onset
measure: Ordinal distribution of mRS at 90 days
timeFrame: 3 months from stroke onset
measure: EQ-5D score at at 90 days
timeFrame: 3 months from stroke onset
measure: Neurological improvement at 24 hours
timeFrame: 24 hours from stroke onset
measure: recanalization post-operation
timeFrame: (Day 0) immediately the surgeon thought the thrombectomy completed and performed a second cerebral angiography .
measure: recanalization at 24 hours
timeFrame: 24 hours after thrombectomy completed
Other outcomes:
measure: Infarction volume at 24 hours
timeFrame: 24 hours after thrombectomy completed
measure: symptomatic intracerebral hemorrhage at 36 hours
timeFrame: 36 hours after thrombectomy completed
measure: Mortality at 90 days
timeFrame: 90 days after thrombectomy completed
Locations:
city: Beijing
country: China
facility: Yunyun Xiong
Study officials:
affiliation: Beijing Tiantan Hospital
name: Yunyun Xiong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: