A prospective, multicenter, single-arm objective performance criteria trial to investigate the safety and efficacy of SINOMED ADPAT for Recanalization Therapy in acute large-vessel occlusive stroke.
This study plans to recruit 164 patients with acute intracranial large-vessel occlusion within 24 hours time window. The Primary endpoint is the instant recanalization rate of target vessel after operation. Secondary efficacy endpoints will include: 1) immediate recanalization rate of the first pass of aspiration; 2) the recanalization time of the target vessel blood flow; 3) the improvement of the postoperative NIHSS score; 4) the ratio of good neurological function (mRS 0-2 points) at 90 days; 5) the success rate of device; 6) the success rate of operation; 7) The proportion of rescue therapy. Safety endpoints will include: 1) the incidence of symptomatic intracranial hemorrhage within 24 hours after operation; 2) all-cause death and stroke-related mortality at 90 days; 3) stroke recurrence rate within 90 days after operation; 4) surgery-related complications; 5) adverse events; 6) serious adverse events; 7) Device defection rate
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Direct Aspiration
Qingwu Yang
Chongqing, China
LIUZHOU People's Hospital
Liuchow, China
Jinzhao Liu
Pujiang, China
Zhongnan Hospital of Wuhan University
Wuhan, China
Instant recanalization rate of target vessel after operation
Instant recanalization rate (mTICI 2b-3) of target vessel after operation
Time frame: Last aspiration
Instant recanalization rate of target vessel after the first aspiration
Instant recanalization rate (mTICI 2b-3) of target vessel after the first aspiration
Time frame: First aspiration
The recanalization time of the target vessel blood flow
The recanalization (mTICI 2b-3) time of the target vessel blood flow
Time frame: Procedure time (femoral artery puncture to recanalization)
The improvement of the postoperative NIHSS score the improvement of the postoperative NIHSS score
NIH Stroke Scale/Score (NIHSS):Calculates the NIH Stroke Scale for quantifying stroke severity.
Time frame: Change in NIHSS score at preoperative、24(-6/+24) hours、7±2 days or discharge
Proportion of good neurological function (mRS 0-2)
The modified Rankin Scale/Score (mRS) : scores of 0 to 2 were defined as good neurological function (treatment success)
Time frame: 90 days
The success rate of device
The intracranial thrombus aspiration catheter was successfully delivered to the occluded segment of the blood vessel and then successfully released, and suction was performed, and the delivery system was successfully withdrawn.
Time frame: Intraoperative
The success rate of operation
The success of recanalization after the final treatment (mTICI 2b-3, allowing the use of rescue therapy)
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Xiangtan Central Hospital
Xiangtan, China
Xiang Yang No.1 Peoples Hospital
Xiangyang, China
Time frame: End of Procedure
The incidence of symptomatic intracranial hemorrhage
Through Heidelberg Bleeding Classification to evaluate the intracranial hemorrhage (National Institutes of Health Stroke Scale (NIHSS) score of ≥4 points)
Time frame: 24(-6/+24) hours
All-cause death and stroke-related mortality
All-cause death and stroke-related mortality
Time frame: 90 days
The rate of Stroke recurrence
The existence of clear imaging evidence to confirm that the target vessel is occluded again, which leads to an ischemic stroke event.
Time frame: 90 days
Procedure-related complications
Procedure-related complications: including arterial rupture, arterial dissection, distal thromboembolism, vascular puncture site complications, etc
Time frame: Intraoperative
Adverse events and serious adverse events
Any adverse events and serious adverse events are associated with clinical trials in human
Time frame: During the clinical trials
The rate of device defection
Device defection
Time frame: Intraoperative