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Clinical Trial Summary

Unfavorable outcomes were associated with failed recanalization of acute large vessel occlusions (LVO). The failed recanalization rate of mechanical thrombectomy (MT) was 12-41% reported in multiple randomized controlled trials (RCT). Possible reasons of failed recanalization included technical failure of access, failure of retrieving thrombus, thrombotic re-occlusion, and pre-existing intracranial atherosclerotic stenosis (ICAS). Several studies have been published on balloon dilation or permanent stenting as rescue approaches for failed thrombectomy in individual cases, but there is no evidence from RCTs regarding this topic. ANGEL-REBOOT aims to close this gap by performing a randomized study of bailout intracranial angioplasty (balloon dilation and/or stenting) for unsuccessful thrombectomy in LVO patients.

Clinical Trial Description

The ANGEL-REBOOT is a multicentered, prospective, randomized, open-label, blinded end-point (PROBE) study. A total of approximately 348 patients within 8 hours of symptom onset of acute ischemic stroke (NIHSS:6-30) , who has the imaging evidence of an occlusion of intracranial internal cerebral artery (ICA),M1 of the middle cerebral artery (MCA),V4 of vertebral artery(VA) or basilar artery (BA) segment, anterior circulation stroke [defined as: NECT or DWI ASPECTS≥6] or posterior circulation stroke [defined as: CTA-SI or DWI pc-ASPECTS≥6 and Pons-Midbrain Index (PMI)<3]. Randomization would take place after failed recanalization after 1-3 attempts(traget vessel eTICI 0-2a) thrombectomy with stent retriever and/or contact aspiration. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups after offering informed content. If the patient is randomized into the bailout angioplasty arm, the choice of balloon dilation or stenting will be left to the discretion of the interventionalist. If the patient is randomized into the thrombectomy alone arm, the interventionalist will decide whether to stop the endovascular recanalization procedure or to perform further recanalization attempts using stent-retrievers and/or aspiration catheters. The primary objective is to compare the efficacy and safety of bailout intracranial angioplasty with MT alone following unsuccessful recanalization by MT in acute LVO patients. The study consists of three visits including 24 hours after treatment, 7 days or discharge, and 90 days. Demographic information, symptoms and signs, laboratory test, neuro-imaging assessment neurological function rating scale will be recorded during the study. The primary endpoint is the modified Rankin's scale (mRS) at 90 days. The study is anticipated to last from October 2021 to March 2024 with 348 participants recruited form about 40 centers in China. All the related investigative organization and individuals will obey the Declaration of Helsinki and Chinese Good Clinical Practice standard. A scheduled Data and Safety Monitoring Board (DSMB) meeting will oversight the safety data of the study. The trial has been approved by Institutional Review Board (IRB) and Ethics Committee (EC) in Being Tiantan hospital, Capital Medical University. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05122286
Study type Interventional
Source Beijing Tiantan Hospital
Contact Baixue Jia, MD
Phone 15010125093
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date January 2022
Completion date September 2023

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