REperfusion Therapy for Acute Ischemic STrOke Due to Large aRtEry Occlusion

Recruiting

• Conditions: Vascular Occlusion; Perfusion Imaging; Mechanical Thrombectomy; Endovascular Treatment; Stroke

• Registration Number: NCT05311605
• Lead Sponsor: Beijing Tiantan Hospital

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.

Study Timeline

• Study First Submitted: 2022-03-28
• Study First Submitted QC: 2022-03-28
• Study First Posted: 2022-04-05
• Study Start: 2023-02-23
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-21
• Primary Completion: 2024-09-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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 at 24 hours	24 hours after thrombectomy completed	proportion of eTICI 2b50/2c/3

Trial Locations

Locations (1)

Yunyun Xiong; 🇨🇳 Beijing, China