scholarly journals Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results

2019 ◽  
Vol 12 (1) ◽  
pp. 62-66 ◽  
Author(s):  
Ricardo A Hanel ◽  
David F Kallmes ◽  
Demetrius Klee Lopes ◽  
Peter Kim Nelson ◽  
Adnan Siddiqui ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Parent Vessel ◽  
Major Morbidity ◽  
Complete Occlusion ◽  
Vessel Stenosis ◽  
Safety Endpoint ◽  
Effectiveness Endpoint ◽  
Primary Safety Endpoint ◽  
Major Stroke

BackgroundPreliminary clinical studies on the safety and efficacy of the pipeline embolization device (PED) for the treatment of small/medium aneurysms have demonstrated high occlusion rates with low complications.ObjectiveTo evaluate the safety and effectiveness of the PED for treatment of wide necked small and medium intracranial aneurysms.MethodsPREMIER is a prospective, multicenter, single arm trial. Patients were treated with the PED for unruptured wide necked aneurysms, measuring ≤12 mm along the internal carotid artery or vertebral artery, between July 2014 and November 2015. At 1 year post-procedure, the primary effectiveness endpoint was complete occlusion (Raymond grade 1) without major parent vessel stenosis (≤50%) or retreatment, and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurologic death.ResultsA total of 141 patients were treated with PEDs (mean age 54.6±11.3 years, 87.9% (124/141) women). Mean aneurysm size was 5.0±1.92 mm, and 84.4% (119/141) measured <7 mm. PED placement was successful in 99.3% (140/141) of patients. Mean number of PEDs implanted per patient was 1.1±0.26; a single PED was used in 92.9% (131/141) of patients. At 1 year, 97.9% (138/141) of patients underwent follow-up angiography with 76.8% (106/138) of patients having met the study’s primary effectiveness endpoint. The combined major morbidity and mortality rate was 2.1% (3/140).ConclusionsTreatment of wide necked small/medium aneurysms with the PED results in high rates of complete occlusion without significant parent vessel stenosis and low rates of permanent neurologic complications.Trial registrationNCT02186561.

scholarly journals Multi-centric European post-market follow-up study of the Neuroform Atlas Stent System: primary results

2021 ◽  
pp. neurintsurg-2021-017849
Author(s):  
Pierre-Henri Lefevre ◽  
Peter Schramm ◽  
André Kemmling ◽  
Xavier Barreau ◽  
Gaultier Marnat ◽  
...  
Keyword(s):  
Medium Size ◽  
Mri Imaging ◽  
Clinical Trial Registration ◽  
Multicentric Study ◽  
Aneurysm Neck ◽  
Stent System ◽  
Safety Endpoint ◽  
Primary Safety Endpoint ◽  
Major Stroke

BackgroundFew prospective series have described the safety and effectiveness of the Neuroform Atlas Stent System. We aimed to investigate the efficacy and safety of the device in patients treated for unruptured aneurysm.MethodsATLAS EU PMCF is a consecutive, prospective, multicentric study that included patients with unruptured saccular aneurysm of all sizes. Follow-up visits were scheduled at 3–6 months and 12–16 months with digital subtraction angiography (DSA) or MRI imaging follow-up as per the site standard of care. The primary efficacy endpoint was adequate aneurysm occlusion (Raymond Roy occlusion grade I and II) on 12 month angiography. The primary safety endpoint was any major stroke or ipsilateral stroke or neurological death within 12 months.ResultsOf the 106 patients consented, 105 were treated with at least one Neuroform Atlas stent. There was a failed implantation attempt in 1 patient, 85 patients received lateral stenting, and 19 patients received Y-stenting. Mean aneurysm neck size was 4.2 mm (range 1.9–33 mm). Adequate occlusion was observed in 95.1% immediately after the procedure and in 98.9% of cases at 1 year DSA follow-up. Overall, 1.0% (1/102; 95% CI 0.0% to 5.3%) of patients experienced a primary safety endpoint of major stroke. Three minor strokes resulted in a modified Rankin Scale score of 2.ConclusionsIn this multicentric, prospective study, stent-assisted coiling of medium size unruptured aneurysms with the Neuroform Atlas stent resulted in a favorable rate of satisfactory occlusion. In our findings, the use of the Y-stenting technique was associated with increased rates of procedural complications.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/NCT02783339.

scholarly journals The Barrel vascular reconstruction device for endovascular coiling of wide-necked intracranial aneurysms: a multicenter, prospective, post-marketing study

2018 ◽  
Vol 10 (10) ◽  
pp. 969-974 ◽  
Author(s):  
Benjamin Gory ◽  
Raphaël Blanc ◽  
Francis Turjman ◽  
Jérôme Berge ◽  
Michel Piotin
Keyword(s):  
Intracranial Aneurysms ◽  
Vascular Reconstruction ◽  
Dome Height ◽  
Endovascular Coiling ◽  
Anterior Communicating Artery ◽  
Parent Artery ◽  
Safety Endpoint ◽  
Post Marketing ◽  
Effectiveness Endpoint ◽  
Primary Safety Endpoint

Background and purposeThe Barrel vascular reconstruction device (Barrel VRD) is a novel stent with design features that allow endovascular coiling of wide-necked bifurcation aneurysms while preserving adjacent branches, without necessitating dual stent implantation. This study aimed to assess the safety and effectiveness of the Barrel VRD at 12-month follow-up.Materials and methodsThe Barrel VRD trial is a prospective, multicenter, observational post-marketing registry evaluating the use of the Barrel VRD for treatment of wide-necked bifurcation aneurysms. The primary effectiveness endpoint was successful aneurysm treatment measured by digital subtraction angiography with a Raymond–Roy occlusion grade of 1 or 2 in the absence of retreatment, parent artery stenosis (>50%), or target aneurysm rupture at 12 months. The primary safety endpoint was the absence of neurological death or major stroke at 12 months.ResultsTwenty patients were enrolled from December 2013 to December 2014. The device was implanted in 19 patients with 19 aneurysms (8 middle cerebral artery, 4 anterior communicating artery, 1 internal carotid artery terminus, 4 basilar artery aneurysms; mean dome height 5.7±1.91 mm; mean neck length 4.8±1.35 mm, mean dome-to-neck ratio 1.6±2.0). Coiling was performed in all cases. The primary effectiveness endpoint was achieved in 78.9% of subjects (15/19; 12 complete occlusions, 3 neck remnants), and the primary safety endpoint was 5.3% (1/19).ConclusionsThis prospective study demonstrates that the Barrel VRD device resulted in ~80% occlusion rates and ~5% rates of neurological complications at 1 year after endovascular treatment of wide-necked bifurcation intracranial aneurysms.Registered clinical trialNCT02125097;Results.

Effectiveness of microsurgery for intracranial aneurysms

1973 ◽  
Vol 39 (6) ◽  
pp. 690-693 ◽  
Author(s):  
Sidney A. Hollin ◽  
Robert E. Decker
Keyword(s):  
Intracranial Aneurysms ◽  
Aneurysm Surgery ◽  
Parent Vessel ◽  
Content Type ◽  
Complete Occlusion ◽  
Microsurgical Technique ◽  
Aneurysm Occlusion ◽  
High Degree ◽  
Fine Print

✓ The authors report postoperative angiographic results in a series of 50 patients who had undergone microsurgery for intracranial aneurysms. The aneurysmal body and fundus were obliterated in every case. The neck was visualized postoperatively in three cases, or 6%; in one of these, later follow-up angiography demonstrated subsequent total aneurysm occlusion. No postoperative rebleeding occurred. The incidence of postoperative occlusion of the parent vessel was small, with complete occlusion in only one case and partial branch occlusion in another. These results confirm the impression that a high degree of accuracy in clip placement is possible with microsurgical technique. Routine postoperative angiography does not appear to be necessary if the surgeon has become skilled in the use of the microscope for aneurysm surgery.

Abstract 125: Treatment of Intracranial Aneurysms With the LUNA AES Updated

Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
NADER SOUROUR ◽  
Michel Piotin ◽  
Raphael Blanc ◽  
Alessandra Biondi ◽  
Charbel Mounayer ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Flow Diverter ◽  
Artery Occlusion ◽  
Prospective Clinical Study ◽  
Parent Artery ◽  
Parent Vessel ◽  
Complete Occlusion ◽  
Parent Artery Occlusion ◽  
Aneurysm Embolization

Purpose: The LUNA Aneurysm Embolization System (AES) is a new self-expanding ovoid device that serves as an intra saccular flow diverter as well as a scaffold for endothelization across the neck. The objective of this prospective clinical study aiming to include a total of 63 patients was to evaluate the ability of the AES to occlude intracranial aneurysms while maintaining patency of the parent artery. Materials and Methods: Immediate post-implantation occlusion grade (complete (complete obliteration of the aneurysm including the neck), near-complete (persistence of any portion of the original defect of the arterial wall), or incomplete (any opacification of the sac) compared to baseline), and parent vessel compromise were evaluated. Patients underwent neurological testing with the Modified Rankin Scale and the National Institute of Health Stroke Scale (NIHSS) at baseline and time of discharge. Follow-up included clinical assessment at one, 3, 6, 9 and 12 months, and angiographic follow-up at 6 and 12 months. Results: 50 patients (9 men) with 47 unruptured and 4 ruptured saccular aneurysms (38 bifurcation, 13 sidewall, sizes from 3.9 to 10.1 mm) were enrolled to date in the study. In all but 2 aneurysms (2 failed procedure converted in coiling) 1 LUNA AES was deployed per aneurysm. In 5 cases, the LUNA AES placement was carried out with balloon microcatheter assistance. In one case, the LUNA AES placement was carried out with a stent. Clinical follow up was uneventful in all but 2 patients (one sustained SAH from a contralateral MCA aneurysm, one had GI bleeding). Immediate complete/near complete occlusion was obtained in 26.5% (13/49). At 6 month follow-up, complete/near complete occlusion was obtained in 70.8% (34/48). There was no parent artery occlusion. None of the treated aneurysm (re)bled during follow-up. 4 aneurysms treated with the LUNA needed retreatment (2 incomplete deployment of the LUNA into the sac, 2 angiographic recurrences). Conclusion: Preliminary results demonstrate good safety profile. Angiographic follow up are promising.

Republished: Late recurrence of a completely occluded large intracranial aneurysm treated with a Tubridge flow diverter

2016 ◽  
Vol 9 (2) ◽  
pp. e6-e6 ◽  
Author(s):  
Xiaoxi Zhang ◽  
Nan Lv ◽  
Chi Wang ◽  
Wei Cao ◽  
Jianmin Liu ◽  
...  
Keyword(s):  
Rare Case ◽  
Late Recurrence ◽  
Flow Diverter ◽  
Probable Mechanism ◽  
Parent Vessel ◽  
Complete Occlusion ◽  
Intracavernous Aneurysm ◽  
Vessel Stenosis ◽  
Flow Diverter Devices

We report a rare case of recurrence of a large intracavernous aneurysm after angiography proved complete occlusion. The aneurysm was treated by a combination of a Tubridge flow diverter and coils, and balloon angioplasty, after flow diverter devices deployment for parent vessel stenosis. Six month angiographic follow-up demonstrated complete occlusion. Unfortunately, obvious aneurysm recurrence was confirmed on 2 year angiographic follow-up. The probable mechanism of recurrence was analyzed.

Contour-Assisted coiling with jailed microcatheter May result in better occlusion (CoCoJaMBO) in wide-necked intracranial aneurysms: Proof of principle and immediate angiographic results

2022 ◽  
pp. 159101992110697
Author(s):  
Fritz Wodarg ◽  
Yigit Oezpeynirci ◽  
Johannes Hensler ◽  
Olav Jansen ◽  
Thomas Liebig
Keyword(s):  
Endovascular Treatment ◽  
Intracranial Aneurysms ◽  
Dome Height ◽  
Parent Vessel ◽  
Complete Occlusion ◽  
Acute Subarachnoid Hemorrhage ◽  
The Mean ◽  
Large And Giant Aneurysms ◽  
Platinum Coils

Purpose Wide-necked bifurcation aneurysms, partially thrombosed, and recurrences of large and giant aneurysms are challenging to treat. We report our preliminary experience with a Contour-assisted coiling technique and discuss the periprocedural safety, feasibility, and effectiveness of the approach. Methods We retrospectively reviewed consecutive patients who received endovascular treatment for intracranial aneurysms with an intra-aneurysmal flow disruptor (Contour) at two neurovascular centres between October 2018 and December 2020 and identified patients treated with a combination of Contour and platinum coils. Clinical and procedural data were recorded. Results For this analysis, 8 patients (5 female) aged 60.1  ±  9.2 years on average were identified. Three of 8 aneurysms were associated with previous acute subarachnoid hemorrhage (SAH). The mean average dome height was 12.8  ±  7.6 mm, mean maximum dome width 10.3  ±  5.4 mm, and neck width 5.5  ±  2.5 mm. The mean dome-to-neck ratio was 1.9  ±  1.0. Immediate complete occlusion of the aneurysm was seen in 5 of 8 cases. In one SAH patient, a parent vessel was temporarily occluded but could be reopened rapidly. One device detached prematurely without any sequelae. No other procedural adverse events were recorded. Conclusion From this initial experience, Contour with adjunctive coiling is a safe and technically feasible method for endovascular treatment of large, wide-necked, partially thrombosed, recurrent, or ruptured bifurcation aneurysms. Further studies with larger numbers of patients and longer follow-up are needed to confirm our results.

scholarly journals Safety and efficacy results of the Flow Redirection Endoluminal Device (FRED) stent system in the treatment of intracranial aneurysms: US pivotal trial

2021 ◽  
pp. neurintsurg-2021-017469
Author(s):  
Cameron G McDougall ◽  
Orlando Diaz ◽  
Alan Boulos ◽  
Adnan H Siddiqui ◽  
Justin Caplan ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Flow Diverter ◽  
Multicenter Trial ◽  
Parent Artery ◽  
Stent System ◽  
Safety Endpoint ◽  
Performance Benchmarks ◽  
Registration Number ◽  
The Usa ◽  
Effectiveness Endpoint

ObjectiveTo evaluate the safety and effectiveness of the Flow Redirection Endoluminal Device (FRED) flow diverter in support of an application for Food and Drug Administration approval in the USA.Methods145 patients were enrolled in a prospective, single-arm multicenter trial. Patients with aneurysms of unfavorable morphology for traditional endovascular therapies (large, wide-necked, fusiform, etc) were included. The trial was designed to demonstrate non-inferiority in both safety and effectiveness, comparing trial results with performance goals (PGs) established from peer-reviewed published literature. The primary safety endpoint was death or major stroke (National Institutes of Health Stroke Scale score ≥4 points) within 30 days of the procedure, or any major ipsilateral stroke or neurological death within the first year. The primary effectiveness endpoint was complete occlusion of the target aneurysm with ≤50% stenosis of the parent artery at 12 months after treatment, and in which an alternative treatment of the target intracranial aneurysm had not been performed.Results145 patients underwent attempted placement of a FRED device, and one or more devices were placed in all 145 patients. 135/145 (93%) had a single device placed. Core laboratory adjudication deemed 106 (73.1%) of the aneurysms large or giant. A safety endpoint was experienced by 9/145 (6.2%) patients, successfully achieving the safety PG of <15%. The effectiveness PG of >46% aneurysm occlusion was also achieved, with the effectiveness endpoint being met in 80/139 (57.6%)ConclusionAs compared with historically derived performance benchmarks, the FRED flow diverter is both safe and effective for the treatment of appropriately selected intracranial aneurysms.Clinical registration numberNCT01801007

scholarly journals Comparative Safety and Efficacy of Left Atrial Appendage Occlusion with the Watchman Device and Amplatzer Cardiac Plug: Results of the Russian National Registry

2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Karapet Davtyan ◽  
Georgiy Simonyan ◽  
Arpi Topchyan ◽  
Andrey Kalemberg ◽  
Alexander Romanov ◽  
...  
Keyword(s):  
Left Atrial ◽  
Left Atrial Appendage ◽  
Primary Efficacy ◽  
Left Atrial Appendage Occlusion ◽  
Safety Endpoint ◽  
Watchman Device ◽  
Comparative Safety ◽  
Major Adverse Events ◽  
Primary Safety Endpoint

Purpose. This multicenter, prospective registry evaluated the comparative safety and efficacy of left atrial appendage occlusion (LAAO) using the Watchman device (WD) and the Amplatzer Cardiac Plug (ACP) in patients with nonvalvular atrial fibrillation (NVAF) in real-world clinical practice in Russia. Methods. The study included data from 200 consecutive NVAF patients ( 66.8 ± 7.8 years, 44.5% female, median CHA2DS2VASc 4, median HAS-BLED 3) who had undergone LAAO implantation using WD ( n = 108 ) or ACP ( n = 92 ) from September 2015 to December 2017 in 5 medical centers in Russia. The primary safety endpoint was the procedure-related major adverse events, and the primary efficacy endpoint was the composite of thromboembolic events, device thrombosis, hemorrhagic events, and unexplained death during the 12-month follow-up. Results. Successful LAAO was performed in all 92 (100%) patients with ACP and 105 (97.2%) with WD ( p = 0.053 ). At 12 months, primary safety endpoint occurred in 6.5% of patients in the ACP group with no events in the WD group (6.5% vs. 0%, p = 0.008 ). During the 12-month follow-up, the primary efficacy endpoint has occurred in 8.3% of patients in the WD group ( n = 9 ) and 1.1% of patients in the ACP group ( n = 1 ) ( p = 0.016 ). Conclusions. In this multicenter prospective registry, LAA closure with the WD was associated with significantly higher thromboembolic events rate in NVAF patients. Patients, receiving the ACP, had more procedure-related major adverse events. However, further multicenter studies are necessary to evaluate these findings.

scholarly journals Endovascular Treatment of Small Ruptured Intracranial Aneurysms (<5 mm)

2019 ◽  
Vol 30 (4) ◽  
pp. 817-826
Author(s):  
Fei Peng ◽  
Xin Feng ◽  
Xin Tong ◽  
Baorui Zhang ◽  
Luyao Wang ◽  
...  
Keyword(s):  
Endovascular Treatment ◽  
Intracranial Aneurysms ◽  
Cox Proportional Hazards ◽  
Parent Artery ◽  
Parent Vessel ◽  
Fisher Grade ◽  
Wide Neck ◽  
Ruptured Intracranial Aneurysms

Abstract Purpose To investigate the long-term clinical and angiographic outcomes and their related predictors in endovascular treatment (EVT) of small (<5 mm) ruptured intracranial aneurysms (SRA). Methods The study retrospectively reviewed patients with SRAs who underwent EVT between September 2011 and December 2016 in two Chinese stroke centers. Medical charts and telephone call follow-up were used to identify the overall unfavorable clinical outcomes (OUCO, modified Rankin score ≤2) and any recanalization or retreatment. The independent predictors of OUCO and recanalization were studied using univariate and multivariate analyses. Multivariate Cox proportional hazards models were used to identify the predictors of retreatment. Results In this study 272 SRAs were included with a median follow-up period of 5.0 years (interquartile range 3.5–6.5 years) and 231 patients with over 1171 aneurysm-years were contacted. Among these, OUCO, recanalization, and retreatment occurred in 20 (7.4%), 24 (12.8%), and 11 (7.1%) patients, respectively. Aneurysms accompanied by parent vessel stenosis (AAPVS), high Hunt-Hess grade, high Fisher grade, and intraoperative thrombogenesis in the parent artery (ITPA) were the independent predictors of OUCO. A wide neck was found to be a predictor of recanalization. The 11 retreatments included 1 case of surgical clipping, 6 cases of coiling, and 4 cases of stent-assisted coiling. A wide neck and AAPVS were the related predictors. Conclusion The present study demonstrated relatively favorable clinical and angiographic outcomes in EVT of SRAs in long-term follow-up of up to 5 years. THE AAPVS, as a morphological indicator of the parent artery for both OUCO and retreatment, needs further validation.

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