RESTORE: REperfusion Therapy for Acute Ischemic STrOke Due to Large aRtEry Occlusion

Sponsor

Beijing Tiantan Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05311605

Collaborator

National Natural Science Foundation of China (Other), Beijing Municipal Science & Technology Commission (Other), Beijing Municipal Administration of Hospitals (Other)

1,600

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Vascular Occlusion Endovascular Treatment Mechanical Thrombectomy Perfusion Imaging

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 total of 1600 patients with advanced imaging data were anticipated to be enrolled.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

REperfusion Therapy for Acute Ischemic STrOke Due to Large aRtEry Occlusion

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Sep 30, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Outcome Measures

Primary Outcome Measures

Favorable functional outcome [3 months from stroke onset]
proportion of mRS score 0-2 at 3 months. The modified Rankin Scale (mRS) has a minimum value of 0 and maximum value of 6. Higher value indicated worse functional outcome

Secondary Outcome Measures

Excellent functional outcome at 90 days [3 months from stroke onset]
proportion of mRS score 0-1 at 3 months
Ordinal distribution of mRS at 90 days [3 months from stroke onset]
Number of participants with the ordinal distribution of mRS at 90 days
EQ-5D score at at 90 days [3 months from stroke onset]
EQ-5D score at 3 months. EuroQol Five Dimensions Questionnaire scale (EQ-5D score) has a minimum value of 0 and maximum value of 100. Lower value indicated worse functional outcome
Neurological improvement at 24 hours [24 hours from stroke onset]
NIHSS score <=1 or improvement of NIHSS score>=4 compared with baseline NIHSS. National Institution Health Stroke Scale (NIHSS) has a minimum value of 0 and maximum value of 45. Higher value indicated worse severity of neurological impairment.
recanalization post-operation [(Day 0) immediately the surgeon thought the thrombectomy completed and performed a second cerebral angiography .]
proportion of eTICI 2b50/2c/3. Thrombectomy is a surgical operation using a retrieve stent or aspiration catheter to remove the thrombus inside an occluded vessel and achieve recanalization.The eTICI is a scale to assess the degree of recanalization. So, once the surgeon thought he completed the thrombectomy, he needed to perform a cerebral angiography to assess the degree of recanalization using eTICI.
recanalization at 24 hours [24 hours after thrombectomy completed]
proportion of eTICI 2b50/2c/3

Other Outcome Measures

Infarction volume at 24 hours [24 hours after thrombectomy completed]
infarction volume: volume of the tissue with CBF <30% or ADC<600×10-6mm2/s
symptomatic intracerebral hemorrhage at 36 hours [36 hours after thrombectomy completed]
symptomatic intracerebral hemorrhage based on Heidelberg criterion
Mortality at 90 days [90 days after thrombectomy completed]
Mortality of all-cause

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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