Acute Ischemic Stroke Clinical Trial
Official title:
The Safety and Efficacy of Intracranial Thrombosis Aspiration Catheter for Recanalization in Acute Ischemic Stroke Therapy- A Prospective, Multicenter, Open Label, Blinded, Randomized Controlled, Non-inferiority Study
This study is a prospective, multi-center, open-label, end-point blinded, randomized, parallel positive control, non-inferiority clinical trial, with a purpose to evaluate the safety and efficacy of Hemo Jirui intracranial thrombus aspiration catheter system for endovascular treatment of acute ischemic stroke by comparison with stent retriever (Solitaire FR). The trial is anticipated to last from November 2018 to May 2019, with 204 subjects recruited from 15-20 clinical trial centers in China.
This study is a prospective, multi-center, open-label, end-point blinded, parallel positive
controlled, non-inferiority clinical trial. Patients with acute ischemic stroke (AIS) who
meet inclusion criteria would be enrolled in this study. Led by Beijing Tiantan Hospital
affiliated to Capital Medical University, this study is planned to be carried out in 15-20
clinical trial institutions in China. There will be 102 patients enrolled in each group.
Patients in the experimental group will be treated with the intracranial thrombus aspiration
catheter, product of Hemo Jirui. Patients in the control group will be treated with stent
retriever (Solitaire FR).
In this trial, relevant examinations of safety and efficacy assessments were performed
immediately after the procedure, at 24 hours, 7 days, 30 days, and 90 days. Primary efficacy
endpoint will be the immediate recanalization rate (mTICI 2b-3) of target vessel after the
procedure. Secondary efficacy endpoints will include: (1) Proportion of functional
independence (mRS 0-2) at 90 days; (2) ordinal shift analysis of mRS at 90 days; (3)
immediate recanalization rate (mTICI 2b-3) of the first pass of thrombectomy device; (4)
immediate recanalization rate (mTICI 2b-3) of the last pass of thrombectomy device;
(5)procedure time (randomization to recanalization); (6) Change in NIHSS score at 24hours;
(7) Change in NIHSS score at 7 days or discharge (whichever comes first); (8) mTICI grading
of target vessel revealed by CTA or MRA at 22-36 hours; (9) The extent of anterior
circulation infarction at 22-36 hours, as measured by ASPECTS on CT or MRI. Safety endpoints
will include: (1) All-cause mortality at 90 days; (2) stroke-related mortality at 90 days;
(3) stroke recurrence rate within 90 days; (4) any type of intracranial hemorrhagic
transformation within 22-36 hours, including parenchymal, subarachnoid or ventricular
hemorrhage; (5) symptomatic intracranial hemorrhage (sICH) within 22-36 hours, as confirmed
by any intracranial hemorrhage on CT or MRI associated with ≥ 4 points of worsening on NIHSS
or even contributing to death; (5) procedural complications or serious adverse events
procedural complications or serious adverse events (SAEs) within 90 days.
The trial is anticipated to last from November 2018 to May 2019, all the related
investigative organization and individuals will obey the Declaration of Helsinki and Chinese
Good Clinical Practice standard. The trial has been approved by Institutional Review Board
(IRB) and Ethics Committee(EC) in Being Tiantan hospital, Capital Medical University.
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