Objective:To evaluate the safety and efficacy of the SeparGateballoon-guiding catheter(BGC)for blocking flow and delivering devices in neurointerventional surgery.Method:This prospective multicenter single-arm trial e...Objective:To evaluate the safety and efficacy of the SeparGateballoon-guiding catheter(BGC)for blocking flow and delivering devices in neurointerventional surgery.Method:This prospective multicenter single-arm trial enrolled patients who received BGC adjuvant therapy to provide temporary blood flow arrest of the supra-aortic arch arteries and their branch vessels in interventional therapy.The primary endpoint was immediate procedural success rate in flow arrest,device delivery,and withdrawal.The efficacy endpoints were intraoperative product performance,including rigidity,smoothness,fracture resistance of the catheter wall,catheter push performance,compatibility and radiopaque display,integrity,adhesion thrombus after withdrawal and balloon rupture.The safety endpoints were adverse and serious adverse events associated with the test device and serious adverse events resulting in death or serious health deterioration.Result:A total of 129 patients were included;of them,128 were analyzed in the full analysis set(FAS)and per protocol set(PPS).Immediate procedural success was achieved in 97.7%of patients with FAS and PPS.The lower bound of the 95%confidence interval was 94.6%,higher than the preset efficacy margin of 94%.Device-related adverse events occurred in 2(1.6%)cases.One was mild adverse event of vasospasm,which resolved spontaneously.The other was serious adverse event of dissection aggravation,which was treated with stenting angioplasty.No device defects were observed.Conclusion:In neurointerventional surgery,the SeparGateBGC can be used to temporarily block the flow of the supra-aortic arch arteries and their branch vessels and guide the interventional device to the target vascular position.展开更多
通过聚甲基丙烯酸甲酯(PMMA)插层改性蒙脱土(MMT)获得了功能化改性蒙脱土(MMT-PMMA),通过刮涂在聚丙烯(PP)微孔膜表面引入MMT-PMMA后,再通过浸涂在微孔膜表面引入单宁酸(TA),制备了具有高电解液润湿性和高耐热性的改性微孔膜(PP/MMT-PMM...通过聚甲基丙烯酸甲酯(PMMA)插层改性蒙脱土(MMT)获得了功能化改性蒙脱土(MMT-PMMA),通过刮涂在聚丙烯(PP)微孔膜表面引入MMT-PMMA后,再通过浸涂在微孔膜表面引入单宁酸(TA),制备了具有高电解液润湿性和高耐热性的改性微孔膜(PP/MMT-PMMA/TA)。接触角测试结果显示,PP微孔膜改性后,电解液接触角由47°降至0°,且电解液吸收率由PP膜的97.5%提高至136.6%,证明PP/MMT-PMMA/TA微孔膜具有良好的电解液亲和性。将微孔膜在不同温度放置30 min测试其耐热性,结果表明,PP/MMT-PMMA/TA微孔膜的耐热性较改性前的PP微孔膜有显著提升。电池性能测试结果表明,经PP/MMT-PMMA/TA微孔膜组装的电池首次充放电容量(60.0 m Ah/g)相比改性前的PP微孔膜(41.3 mAh/g)提升了45%,且倍率性能更好。展开更多
Background and purpose:Stent retriever thrombectomy is the standard therapeutic approach for ischemic stroke with acute large-vessel occlusion.This study evaluated the safety and efficacy of a new thrombectomy device(...Background and purpose:Stent retriever thrombectomy is the standard therapeutic approach for ischemic stroke with acute large-vessel occlusion.This study evaluated the safety and efficacy of a new thrombectomy device(Skyflow)in the treatment of acute ischemic stroke.Methods:After an arterial occlusion model was established,stent-retriever thrombectomy was performed.Digital subtraction angiography(DSA)and autopsy were carried out immediately after thrombectomy in six animals in the acute experimental group.Simulated stent-retriever thrombectomy was performed for three animals in the subacute experimental group,and follow-up angiography and vascular pathological examination were assessed 90 days after the operation.In the clinical trial,192 patients with intracranial anterior circulation large vessel occlusion,within 8 h of symptom onset,were included to undergo thrombectomy with either Skyflow or Solitaire FR stent retriever.Efficacy and safety endpoints were recorded(including successful reperfusion,favorable clinical outcomes,time from puncture to reperfusion,instrument operation success rates and National Institutes of Health Stroke Scale(NIHSS)scores at 7 days for efficacy endpoints,and symptomatic intracranial hemorrhage(sICH),subarachnoid hemorrhage(SAH)and all-cause mortality rates for safety endpoints).Results:All blood vessels achieved successful recanalization in the animal models.In the clinical trial,successful recanalization was attained in 88.4%of patients of the Skyflow group,which was comparable to that of the Solitaire FR group(82.5%)in the full analysis set of the clinical trial.There were no severe complications on DSA,an animal autopsy,or vessel pathological examination in animal experiments.Additionally,no statistically significant difference was observed between the Skyflow and Solitaire FR groups in the clinical trial regarding the safety endpoints.Conclusion:This study showed that the new Skyflow stent retriever is safe and effective for the treatment of acute large vessel occlusion,as demonstrated in our animal study and human trial.展开更多
Background:Previous single-center studies have demonstrated that drug-coated balloons(DCBs)may reduce restenosis rates,which is an important factor affecting the prognosis for intracranial interventional therapy.Howev...Background:Previous single-center studies have demonstrated that drug-coated balloons(DCBs)may reduce restenosis rates,which is an important factor affecting the prognosis for intracranial interventional therapy.However,currently available cardiac DCBs are not always suitable for the treatment of intracranial atherosclerotic stenosis(ICAS).This study aimed to evaluate the safety and efficacy of a novel DCB catheter designed for patients with severely symptomatic ICAS.Methods:This prospective,multicenter,single-arm,target-value clinical trial was conducted in 9 Chinese stroke centers to evaluate the safety and efficacy of a novel DCB catheter for treating symptomatic severe ICAS.Primary metrics and other indicators were collected and analyzed using SAS version 9.4(SAS Institute,Cary,NC,USA).Results:A total of 155 patients were enrolled in this study.The preliminary collection of follow-up data has been completed,while data quality control is ongoing.Conclusion:Results of this study demonstrated the patency rate,safety,and effectiveness of a novel on-label paclitaxel DCB designed for the treatment of ICAS.Ethics and dissemination:This study,involving human participants,was reviewed and approved by the Ethics Committee of Drugs(Devices)Clinical Experiment at Henan Provincial People’s Hospital(reference number:2020-145-03)and other research centers participating in the clinical trial.The results of this study will be presented at international conferences and sent to peer-reviewed journals for publication.Standard protocol items:The Recommendations for Interventional Trials checklist was used when drafting the study protocol.Trial registration number:Registered with the Chinese Clinical Trial Registry on June 11,2021(Chi CTR2100047223).展开更多
Polypropylene microporous membranes are typical hydrophobic separation membranes, but the high hydrophobicity and lack of functionality easily cause bacterial adhesion, thus inducing membrane pollution. Poly（AMS-co-D...Polypropylene microporous membranes are typical hydrophobic separation membranes, but the high hydrophobicity and lack of functionality easily cause bacterial adhesion, thus inducing membrane pollution. Poly（AMS-co-DMAEMA） （PAD） was designed and synthesized by copolymerization of a-methyl styrene （AMS） and functional monomer 2-（dimethylamino）ethyl methacrylate （DMAEMA）, and then grafted onto PP chains by melt blending. Microporous membranes of blended PP containing different contents of PAD are made by casting and stretching, and the polycation microporous membrane is then obtained via quaternization. The permeability and porosity of the microporous membrane achieve the best when the grafting efficiency reaches 42.16%, and the hydrophilicity of the microporous membrane is improved. The results show that the modified membranes fabricated in this method have good antibacterial properties.展开更多
基金supported by the Co-construction of Provincial and Ministry Youth Project(SBGJ202003004)Scientific and Technological Project of Henan Province(202102310037)。
文摘Objective:To evaluate the safety and efficacy of the SeparGateballoon-guiding catheter(BGC)for blocking flow and delivering devices in neurointerventional surgery.Method:This prospective multicenter single-arm trial enrolled patients who received BGC adjuvant therapy to provide temporary blood flow arrest of the supra-aortic arch arteries and their branch vessels in interventional therapy.The primary endpoint was immediate procedural success rate in flow arrest,device delivery,and withdrawal.The efficacy endpoints were intraoperative product performance,including rigidity,smoothness,fracture resistance of the catheter wall,catheter push performance,compatibility and radiopaque display,integrity,adhesion thrombus after withdrawal and balloon rupture.The safety endpoints were adverse and serious adverse events associated with the test device and serious adverse events resulting in death or serious health deterioration.Result:A total of 129 patients were included;of them,128 were analyzed in the full analysis set(FAS)and per protocol set(PPS).Immediate procedural success was achieved in 97.7%of patients with FAS and PPS.The lower bound of the 95%confidence interval was 94.6%,higher than the preset efficacy margin of 94%.Device-related adverse events occurred in 2(1.6%)cases.One was mild adverse event of vasospasm,which resolved spontaneously.The other was serious adverse event of dissection aggravation,which was treated with stenting angioplasty.No device defects were observed.Conclusion:In neurointerventional surgery,the SeparGateBGC can be used to temporarily block the flow of the supra-aortic arch arteries and their branch vessels and guide the interventional device to the target vascular position.
文摘通过聚甲基丙烯酸甲酯(PMMA)插层改性蒙脱土(MMT)获得了功能化改性蒙脱土(MMT-PMMA),通过刮涂在聚丙烯(PP)微孔膜表面引入MMT-PMMA后,再通过浸涂在微孔膜表面引入单宁酸(TA),制备了具有高电解液润湿性和高耐热性的改性微孔膜(PP/MMT-PMMA/TA)。接触角测试结果显示,PP微孔膜改性后,电解液接触角由47°降至0°,且电解液吸收率由PP膜的97.5%提高至136.6%,证明PP/MMT-PMMA/TA微孔膜具有良好的电解液亲和性。将微孔膜在不同温度放置30 min测试其耐热性,结果表明,PP/MMT-PMMA/TA微孔膜的耐热性较改性前的PP微孔膜有显著提升。电池性能测试结果表明,经PP/MMT-PMMA/TA微孔膜组装的电池首次充放电容量(60.0 m Ah/g)相比改性前的PP微孔膜(41.3 mAh/g)提升了45%,且倍率性能更好。
基金supported by the Co-construction of Provincial and Ministry Youth Project(SBGJ202003004)Key Research and Development Program of Henan Province(Scientific and Technological Project of Henan Province)(202102310037)
文摘Background and purpose:Stent retriever thrombectomy is the standard therapeutic approach for ischemic stroke with acute large-vessel occlusion.This study evaluated the safety and efficacy of a new thrombectomy device(Skyflow)in the treatment of acute ischemic stroke.Methods:After an arterial occlusion model was established,stent-retriever thrombectomy was performed.Digital subtraction angiography(DSA)and autopsy were carried out immediately after thrombectomy in six animals in the acute experimental group.Simulated stent-retriever thrombectomy was performed for three animals in the subacute experimental group,and follow-up angiography and vascular pathological examination were assessed 90 days after the operation.In the clinical trial,192 patients with intracranial anterior circulation large vessel occlusion,within 8 h of symptom onset,were included to undergo thrombectomy with either Skyflow or Solitaire FR stent retriever.Efficacy and safety endpoints were recorded(including successful reperfusion,favorable clinical outcomes,time from puncture to reperfusion,instrument operation success rates and National Institutes of Health Stroke Scale(NIHSS)scores at 7 days for efficacy endpoints,and symptomatic intracranial hemorrhage(sICH),subarachnoid hemorrhage(SAH)and all-cause mortality rates for safety endpoints).Results:All blood vessels achieved successful recanalization in the animal models.In the clinical trial,successful recanalization was attained in 88.4%of patients of the Skyflow group,which was comparable to that of the Solitaire FR group(82.5%)in the full analysis set of the clinical trial.There were no severe complications on DSA,an animal autopsy,or vessel pathological examination in animal experiments.Additionally,no statistically significant difference was observed between the Skyflow and Solitaire FR groups in the clinical trial regarding the safety endpoints.Conclusion:This study showed that the new Skyflow stent retriever is safe and effective for the treatment of acute large vessel occlusion,as demonstrated in our animal study and human trial.
基金funded by The Henan Province Young and Middle-aged Health Science and Technology Innovation Young Talent Training Project(,Grant/Award Number:YXKC20200041)National Health Commission Capacity Building and Continuing Education Project(Grant/Award Number:GWJJ2023100101)
文摘Background:Previous single-center studies have demonstrated that drug-coated balloons(DCBs)may reduce restenosis rates,which is an important factor affecting the prognosis for intracranial interventional therapy.However,currently available cardiac DCBs are not always suitable for the treatment of intracranial atherosclerotic stenosis(ICAS).This study aimed to evaluate the safety and efficacy of a novel DCB catheter designed for patients with severely symptomatic ICAS.Methods:This prospective,multicenter,single-arm,target-value clinical trial was conducted in 9 Chinese stroke centers to evaluate the safety and efficacy of a novel DCB catheter for treating symptomatic severe ICAS.Primary metrics and other indicators were collected and analyzed using SAS version 9.4(SAS Institute,Cary,NC,USA).Results:A total of 155 patients were enrolled in this study.The preliminary collection of follow-up data has been completed,while data quality control is ongoing.Conclusion:Results of this study demonstrated the patency rate,safety,and effectiveness of a novel on-label paclitaxel DCB designed for the treatment of ICAS.Ethics and dissemination:This study,involving human participants,was reviewed and approved by the Ethics Committee of Drugs(Devices)Clinical Experiment at Henan Provincial People’s Hospital(reference number:2020-145-03)and other research centers participating in the clinical trial.The results of this study will be presented at international conferences and sent to peer-reviewed journals for publication.Standard protocol items:The Recommendations for Interventional Trials checklist was used when drafting the study protocol.Trial registration number:Registered with the Chinese Clinical Trial Registry on June 11,2021(Chi CTR2100047223).
基金supported by the National Natural Science Foundation of China(Nos. 21778055 and 21573250)
文摘Polypropylene microporous membranes are typical hydrophobic separation membranes, but the high hydrophobicity and lack of functionality easily cause bacterial adhesion, thus inducing membrane pollution. Poly（AMS-co-DMAEMA） （PAD） was designed and synthesized by copolymerization of a-methyl styrene （AMS） and functional monomer 2-（dimethylamino）ethyl methacrylate （DMAEMA）, and then grafted onto PP chains by melt blending. Microporous membranes of blended PP containing different contents of PAD are made by casting and stretching, and the polycation microporous membrane is then obtained via quaternization. The permeability and porosity of the microporous membrane achieve the best when the grafting efficiency reaches 42.16%, and the hydrophilicity of the microporous membrane is improved. The results show that the modified membranes fabricated in this method have good antibacterial properties.
