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

Capital Medical University

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT05311605

KY-2022-029-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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