Endovascular Aneurysm Treatment with the Numen Coil Embolization System: A Prospective Randomized Controlled Open-Label Multicenter Noninferiority Trial in China.

OBJECTIVE: We investigated the safety and efficacy of the Numen coil compared with the Axium coil in the treatment of intracranial aneurysms. METHODS: Because CATCH (Coil Application Trial in China) is a prospective randomized controlled open-label noninferiority trial conducted in 10 centers across China, patients who fulfilled the inclusion and exclusion criteria were randomized 1:1 to either a test group (Numen) or a control group (Axium). The primary outcome was based on successful aneurysm occlusion at 6 months follow-up, whereas secondary outcomes included technical success, the recanalization and retreatment rates, and the rate of serious adverse events (SAEs) at 6 months and 12 months follow-up. RESULTS: Between August 2017 and December 2019, 350 patients presenting with 350 aneurysms were enrolled and randomized. Per-protocol analysis showed that the successful aneurysm occlusion rate at 6 months was 91.18% for the test group compared with 91.85% in the control group, with a difference of -0.68% (P = 0.8419), and the overall mortality during the 30-day follow-up period was 1.19% and 1.81% in the test and control group, respectively, showing no significant difference between the 2 groups (P = 0.6837), whereas the SAE incidence during the 12-month follow-up period was 12.50% and 17.47% in the test and control groups, respectively, which was not statistically significant (P = 0.2222). CONCLUSIONS: This trial showed that the Numen coil was noninferior to the Axium coil in terms of intracranial aneurysm embolization and can be considered as a safe and effective coil for treating patients with intracranial aneurysm in clinical practice.

Effect of thrombotic burden on the clinical outcome of endovascular recanalization in large vessel occlusion stroke / 中华放射学杂志

Objective:To investigate the effect of thrombus burden on the clinical outcome of endovascular recanalization in large vessel occlusive stroke.Methods:Patients with acute anterior circulation occlusion who underwent endovascular treatment within 24 hours after onset in Zhengzhou University People′s Hospital from January 2018 to December 2019 were retrospectively collected. According to the clot burden score (CBS) of DSA, total objectives were divided into CBS≥6 group (24 cases) and CBS<6 group (38 cases). Clinical data of the two groups were collected and the modified Rankin scale (mRS) was used to evaluate the clinical outcome at 90 days after surgery. Independent sample t-test, Wilcoxon rank sum test and χ 2 test were used to compare the clinical data between the two groups. Independent risk factors affecting the clinical outcome were analyzed by binary logistic regression. Results:There were no statistically significant differences in basic demographic data, stroke risk factors and other factors between the CBS≥6 group and CBS<6 group ( P>0.05).The proportion of using tirofiban after surgery in the CBS≥6 group (63.2%, 24/38) was lower than that in the CBS<6 group (87.5%, 21/24) (χ2=4.380, P=0.044). The discharge NIHSS score of the CBS≥6 group was [5.0 (3.3, 7.8) points] lower than CBS<6 group [8.5 (1.8, 14.5) points] ( Z=5.221, P=0.022). The proportion of postoperative mRS 0-2 was (91.7%, 22/24) in the CBS≥6 group higher than CBS<6 group(39.5%, 15/38) (χ2=20.486, P=0.001), there were no statistically significant differences between the two groups ( P<0.05). The results of binary logistics regression analysis showed the CBS groups (OR=0.042, 95%CI 0.007-0.244 , P=0.001) was an independent risk factor affecting good outcome. Subgroup analysis of whether tirofiban was used or not showed there was no statistically significant difference in clinical prognosis between the two groups ( P>0.05). Conclusions:The clinical outcome of CBS≥6 group is significantly better than that of CBS<6 group, and patients with small thrombus burden are more likely to get a good clinical outcome of 90 days.

Effect observation of balloon-mounted stent for revascularization of acute vertebral basilar artery occlusion underlying intracranial atherosclerotic disease / 中华放射学杂志

Objective:To investigate the efficacy and safety of endovascular recanalization treatment for acute vertebral basilar artery occlusion (AVBAO) underlying intracranial atherosclerotic disease (ICAD) using a balloon-mounted stent.Methods:A total of 16 cases of consecutive AVBAO patients who underwent endovascular treatment with the balloon-mounted stent within 24 h after onset were retrospectively enrolled in Henan Provincial People′s Hospital from February 2017 to August 2019. And the recanalization rate, operation-related complications, symptomatic intracranial hemorrhage, the improvement of 1 week National Institutes of Health Stroke Scale (NIHSS) score and 3 months modified Rankin Scale (mRS) after treatment were recorded.Results:In all of the 16 patients, 4 patients underwent direct stenting angioplasty, 12 patients received salvage stenting. Stent placement was successful in all 16 patients. Balloon-mounted stent were implanted in basilar artery of 4 cases, in intracranial segment of vertebral artery of 8 cases, and in origination segment of vertebral artery of 4 cases. Recanalization was successful (thrombolysis in cerebral infarction grade 2b and 3) in 15 patients. The time between arterial puncture and recanalization was 79.0 (72.3, 109.3) min. One patient experienced distal thrombosis during surgery. Two patients suffered symptomatic intracranial hemorrhage within 48 h after surgery. The scores of the NIHSS were improved more than 4 points at 1 week after operation in 8 patients. At 3 months follow-up, 9 patients had a good outcome (mRS 0-3 points) and 4 patients died.Conclusion:Selective stenting angioplasty treatment with a balloon-mounted stent seems to be feasible and safe for AVBAO patients underlying ICAD.

Safety and efficacy of the treatment for symptomatic atherosclerotic high-grade stenosis in middle cerebral artery with Wingspan stent / 中华放射学杂志

Objective To assess the safety and efficacy of the treatment for symptomatic atherosclerotic high-grade stenosis in middle cerebral artery with Wingspan stent.Methods The medical records of Wingspan stenting for 102 cases with symptomatic middle cerebral artery high-grade stenosis from February 2008 to May 2012 in our hospital were reviewed retrospectively.All of the patients suffered from ischemic stroke or transient ischemic attack ( TIA ) attributed to the atherosclerotic high-grade stenosis in middle cerebral artery and the stenosis of 70%to 99%was confirmed by DSA before the stenting procedure.All the stroke, death, TIA within 30 days after the stenting procedure or during the follow-up beyond 30 days were observed and recorded.In-stent restenosis were recorded after DSA or CTA was performed 6 months later.χ2 test or Fisher exact test was used to compare in-stent restenosis rate among patients with different clinical and pathological conditions.Results Stenting procedure were successfully performed in 100 patients (98.0%,100/102).The mean degree of stenosis was reduced from (81.0 ±8.4)% to (15.3 ±6.7)%right after surgery.Eight adverse cardiovascular events (7.8 %, 8/102) occured within 30 days ,including seven stroke or death ( 6.9%, 7/102 ) and 1 TIA.The mean clinical follow-up duration was ( 29 ± 15) months in 82 patients, and 9 ischemic events were documented (4 cases of ipsilateral recurrent stroke , 3 cases of ipsilateral TIA, and 2 cases of contralateral ischemic stroke ).The mean radiological follow-up duration was (11 ±9) months in 55 patients.Among them, 8 patients (14.3%) had in-stent restenosis and 3 patients had symptomatic restenosis.The restenosis rate in patients with age ≤49 years.(25.0%,7/28) was higher than those with age >49 years ( 3.7%,1/27 ) ( P>0.05 ).The restenosis rate in patients with lesion size>7.5 mm(25.0%,7/28) was higher than those with lesion size ≤7.5 mm (3.7%,1/27)(P>0.05).Conclusions The treatment of symptomatic middle cerebral artery high-grade stenosis with Wingspan system was relatively safe and associated with a low perioperative complication rate.The long-term efficacy of the treatment for symptomatic atherosclerotic high-grade stenosis in middle cerebral artery with Wingspan stent is prominent.