An interventional study of Stent Retriever in Acute Ischemic Stroke, sponsored by Changhai Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-08-09.
Sponsored by Changhai Hospital · Not applicable, Interventional, and Treatment
As this will be a pre-market registration trial, in which devices will be used in accordance with appropriately labeled indications, pre-study notifications and approval requests will be addressed with CFDA. All trial results will be shared with CFDA.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 239 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Changhai Hospital is the lead sponsor of 342 studies on the registry; 133 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Imaging Exclusion Criteria:
Subject has CT scan or MRI evidence of the following:
Other unusual morphology or lesion that might interfere with device use, including but not limited to the following:
No transfemoral or alternative access, such as:
Device: Stent Retriever
Device: Stent Retriever
Stent Retriever for acute ischemic stroke
Successful Recanalization Rate
Defined as modified treatment in cerebral infarction (mTICI) ≥ 2b
Time frame: immediate post-thrombectomy (t-0) and no later than 3 hours' post-procedure (t-3)
mRS at D90
The modified Rankin Scale (mRS), a combined clinical/functionality and secondary safety endpoint, reflects the degree of disability or dependence in activities of daily living among treated patients. Though listed and classified separately, in multiple publications, as a functionality or clinical endpoint and because of its prominent and unique value in stroke trials, mRS should be considered first among key safety parameters in subjects who complete the 90-day evaluation. A successful endpoint will be defined as follows: "at 90± 14 days' post-treatment, the frequency of mRS scores ≤2 or a post-treatment decrease in mRS score of ≥2, relative to the baseline determination". Patients who die, between thrombectomy initiation and 90-Days, will be given an mRS value of 6 in this analysis.
Time frame: 90± 14 days' post-treatment
Time from puncture to mTICI≥2b
Time from puncture to mTICI≥2b
Time frame: immediate post-thrombectomy (t-0)
The NIHSS score at 30H post-treatment
The NIHSS score at 30H post-treatment
Time frame: 30± 6 hours' post-treatment
Symptomatic intracranial hemorrhage(sICH) within 30H post-treatment
Any intracranial hemorrhage judged by CT(or MRI) with neurological symptoms
Time frame: 30±6 hours' post-treatment
Death within 90D post-treatment
Any cause death within 90D post-treatment
Time frame: 90± 14 days' post-treatment
AE/SAE within 90D post-treatment
Any cause AE/SAEs within 90D post-treatment
Time frame: 90± 14 days' post-treatment
Stentretriever/procedure/stroke related AE/SAEs within 90D post-treatment
Stentretriever/procedure/stroke related AE/SAEs within 90D post-treatment
Time frame: 90± 14 days' post-treatment
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Changhai Hospital