scholarly journals Clinical safety and efficacy of a novel thin-strut cobalt-chromium coronary stent system: Results of the real world Coroflex Blue Registry

2009 ◽  
pp. NA-NA
Author(s):  
Wolfgang Bocksch ◽  
Francisco Pomar ◽  
Mieczyslaw Dziarmaga ◽  
Damras Tresukosol ◽  
Omar Ismail ◽  
...  
Keyword(s):  
Real World ◽  
Coronary Stent ◽  
Cobalt Chromium ◽  
Clinical Safety ◽  
Safety And Efficacy ◽  
The Real ◽  
Stent System

The real world experience of the biodegradable polymer-coated sirolimus-eluting coronary stent system

2014 ◽  
Vol 88 (3) ◽  
pp. E93-E98 ◽  
Author(s):  
D. Rajasekhar ◽  
V. Vanajakshamma ◽  
C. Shashank ◽  
M.L. Srinivasakumar ◽  
C. Sivasankara
Keyword(s):  
Real World ◽  
Biodegradable Polymer ◽  
Coronary Stent ◽  
The Real ◽  
Stent System

Safety and Efficacy of the cobalt chromium PRO-Kinetik coronary stent system: Results of the MULTIBENE study

2012 ◽  
Vol 13 (6) ◽  
pp. 316-320 ◽  
Author(s):  
Paul Vermeersch ◽  
Yolande Appelman ◽  
Dieter Horstkotte ◽  
Gert Richardt ◽  
Jean Boland ◽  
...  
Keyword(s):  
Coronary Stent ◽  
Cobalt Chromium ◽  
Safety And Efficacy ◽  
Stent System

The Real World Experience of the Everolimus-Eluting Coronary Stent System: Audit of Everolimus-Eluting Coronary Stents

2011 ◽  
Vol 24 (3) ◽  
pp. 241-246 ◽  
Author(s):  
SALLY ALDOUS ◽  
DAVID SMYTH ◽  
JAMES BLAKE ◽  
DOUGAL MCCLEAN ◽  
JOHN ELLIOTT
Keyword(s):  
Real World ◽  
Coronary Stents ◽  
Coronary Stent ◽  
The Real ◽  
Stent System

scholarly journals TCT-485 A study of safety and efficacy of biodegradable polymer coated Everolimus-eluting coronary stent system [Everoflex] at intermediate follow-up in real world scenario

2016 ◽  
Vol 68 (18) ◽  
pp. B194-B195
Author(s):  
Rajasekhar Durgaprasad ◽  
Velam Vanajakshamma ◽  
Vamsidhar Akkulagari ◽  
Latheef Kasala ◽  
Sreedhar Naik Kanavat ◽  
...  
Keyword(s):  
Real World ◽  
Biodegradable Polymer ◽  
Coronary Stent ◽  
Safety And Efficacy ◽  
Stent System

scholarly journals All-case Japanese post-marketing surveillance of the real-world safety and efficacy of rituximab treatment in patients with refractory nephrotic syndrome

2021 ◽  
Author(s):  
Mana Kobayashi ◽  
Yutaro Kageyama ◽  
Takashi Ando ◽  
Junko Sakamoto ◽  
Shohji Kimura
Keyword(s):  
Nephrotic Syndrome ◽  
Standard Deviation ◽  
Real World ◽  
Pediatric Patients ◽  
Safety And Efficacy ◽  
The Real ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Refractory Nephrotic Syndrome ◽  
Observation Period

Abstract Background Rituximab is conditionally approved in Japan for use in patients with refractory nephrotic syndrome. To meet the conditions of approval, an all-case post-marketing surveillance study was conducted to confirm the real-world safety and efficacy of rituximab in patients of all ages with refractory nephrotic syndrome. Methods All patients scheduled to receive rituximab treatment for refractory nephrotic syndrome were eligible to register (registration: August 29, 2014 through April 15, 2016); the planned observation period was 2 years from the initiation of rituximab treatment (intravenous infusion, 375 mg/m2 once weekly for four doses). The study was conducted at 227 hospitals throughout Japan. Adverse drug reactions (ADRs) were collected for safety outcomes. The efficacy outcomes were relapse-free period and the degree of growth in pediatric (< 15 years) patients. Results In total, 997 (447 pediatric) patients were registered; 981 (445) were included in the safety analysis set; 852 (402) completed the 2-year observation period; and 810 (429) were included in the efficacy analysis set. Refractory nephrotic syndrome had developed in childhood for 85.0% of patients, and 54.6% were aged ≥15 years. ADRs were observed in 527 (53.7%) patients, treatment-related infection/infestation in 235 (24.0%) patients, and infusion reactions in 313 (31.9%) patients. The relapse-free period was 580 days (95% confidence interval, 511–664). There was a significant change in height standard deviation score (pediatric patients; mean change, 0.093; standard deviation, 0.637; P = 0.009). Conclusion The safety and efficacy of rituximab treatment in patients with refractory nephrotic syndrome were confirmed in the real-world setting. Clinical trial registration UMIN000014997.

Abstract 1122‐000142: Safety and Efficacy of Surpass Streamline for Intracranial Aneurysms: A Multicenter US Real‐World Experience (SESSIA)

2021 ◽  
Vol 1 (S1) ◽  
Author(s):  
Juan Vivanco‐Suarez ◽  
Alan Mendez‐Ruiz ◽  
Farooqui Mudassir ◽  
Cynthia B Zevallos ◽  
Milagros Galecio‐Castillo ◽  
...  
Keyword(s):  
Real World ◽  
Intracranial Aneurysms ◽  
The United States ◽  
Chromium Alloy ◽  
Cobalt Chromium ◽  
Anterior Circulation ◽  
Safety And Efficacy ◽  
Post Marketing ◽  
The Mean

Introduction : Flow diversion has established itself as standard treatment of wide complex intracranial aneurysms (IA). Its recognition has been validated with positive occlusion rates and favorable clinical outcomes. The Surpass Streamline (SS) flow diverter (FD) is a braided cobalt/chromium alloy implant with 72 or 96 wires approved by the FDA in 2018. The aim of this study is to determine the safety and efficacy of the SS in a post‐marketing large US cohort. Methods : We performed a multicenter, retrospective study for consecutive patients treated with the SS FD for IA between January 2018 and June 2021 in the United States. Inclusion criteria for participants were: 1. Adults (≥ 18 years) and 2. Treatment with SS FD for IA. Primary safety end point was a major ipsilateral stroke (increase in National Institutes of Health Stroke Scale Score of ≥ 4) or neurological death within 12 months. Primary efficacy was assessed using the 3‐point Raymond‐Roy (RR) occlusion scale on digital subtraction angiography (DSA) at 6‐12‐month follow‐up. Results : A total of 276 patients with 313 aneurysms were enrolled. The median age was 59 years and 199 (72%) were females. The most common comorbidities included hypertension in 156 (57%) subjects followed by hyperlipidemia in 76 (28%) patients. One hundred and twenty‐two (44%) patients were asymptomatic while subarachnoid hemorrhage was present in only 10 (4%) patients. A total of 143 (46%) aneurysms were left‐sided. Aneurysms were located as follows: 274 (88%) were in the anterior circulation with paraophthalmic being the most common in 120 (38%) followed by petrocavernous ICA in 81 (26%); 33 (11%) aneurysms were located in the posterior circulation with basilar trunk being the most common in 14 (5%). The mean maximum aneurysm dome width was 5.77 ± 4.7 mm, neck width 4.22 ± 3.8 mm and dome to neck ratio was 1.63 ± 1.3 mm. The mean number of SS FD implanted per aneurysm was 1.06 (range 1–3) with more than one SS FD implanted in 21 (7%) aneurysms. Modified Rankin Scale (mRS) of 0–2 was present in 206/213 (97%) patients at 6–12 month follow‐up. The complete aneurysm occlusion (RR 1) rate was 145/175 (83%) among subjects who had angiographic follow‐up at 6–12 months. Major stroke and death was encountered in 7 (2%) and 5 (1.8%) of the patients respectively. Conclusions : Our data represent the largest real‐world study using SS FD. These results corroborate its post‐marketing safety and efficacy for the treatment of intracranial aneurysms showing more favorable rates to the initial experience during SCENT trial.

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