Safety and efficacy of the SeparGateTM balloon-guiding catheter in neurointerventional surgery:A prospective,multicenter,single-arm clinical trial

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.

Polytetrafluoroethylene-covered stent implantation with double guiding catheter technique for the treatment of type III coronary perforation after stenting

Coronary artery perforation is a life-threatening , complication during percutaneous coronary intervention （PCI） although it occurs rarely in contemporary era with incidence ranging from 0.1% to 0.8%. The overall mortality remains quite high and varied with thestype of perforation, with higher risk in type Ⅱ and Ⅲ

Guiding extension catheter facilitated percutaneous coronary intervention for a dextrocardia patient with acute left anterior descending artery occlusion:a case report

Dextrocardia refers to a right-sided location of the heart within the thoracic cavity which is the primary manifestation of the abnormal lateralisation of the embryonic leftright axis.[1]As a rare cardiac malformation,the prevalence rate of dextrocardia is between 1/6000 to 1/35000 live births.[2]It is reported that the incidence rate of coronary artery disease for dextrocardia patients is similar for patients without dextrocardia.However,the detailed information including electrocardiogram(ECG)manifestation and percutaneous coronary intervention(PCI)technique for dextrocardia patients is still limited.[3,4]Herein,we report a dextrocardia patient who was diagnosed by modified ECG and treated by trans-radial PCI facilitated with guiding extension catheter(GEC).

A simple practical balloon anchoring technique within the guide catheter for chronic total occlusion (CTO) of the coronary artery

Dear Editor： Chronic total occlusions （CTOs） of the coronary artery are commonly encountered complex lesionst11. Percutaneous coronary intervention （PCI） for CTO is technically challenging due to low procedural success ratesTM. Microcatheter is one of the important devices for treatment of CTOTM. It has been widely used attributed to the excellent crossability whenever angula- tion and tortuousity of the coronary artery is encoun- tered. In the process, the microcatheter has to be withdrawn from the guide wire after the wire is proved to locate in the true lumen.