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Background and objectiveStent-assisted coil embolization is a well-established treatment of intracranial wide-necked aneurysms. The Neuroform Atlas Stent System is a new generation microstent designed to enhance coil support, conformability, deliverability, and improve deployment accuracy. We present the 1-year efficacy and angiographic results of the Humanitarian Device Exemption (HDE) cohort from the Atlas Investigational Device Exemption (IDE) clinical trial.MethodThe Atlas IDE trial is a prospective, multicenter, single-arm, open-label study of unruptured wide-necked intracranial aneurysms treated with the Neuroform Atlas stent and approved coils. The primary efficacy endpoint was the rate of 12-month complete aneurysm angiographic occlusion (Raymond class I) without target aneurysm retreatment or significant parent artery stenosis (>50%) at the target location. The primary safety endpoint was the rate of major ipsilateral stroke or neurological death within 12 months. Imaging core laboratory and Clinical EventsCommittee adjudicated the primary endpoints.Results30 patients were enrolled at eight US centers, with 27 patients completing the 12-month angiographic follow-up. The mean age was 59.4±11.8 years and 24/30 patients (80%) were women. The mean aneurysm size was 5.3±1.7 mm and the dome:neck ratio was 1.1±0.2. Procedural technical success of Neuroform Atlas Stent deployment was 100%. 27 patients completed 12-month angiographic follow-up and 30 patients completed their 6-month follow-up. When applying the last observation carried forward method, the primary efficacy endpoint was observed in 26/30 patients (86.7%, 95% CI 69.3% to 96.2%) compared with 25/27 patients (92.6%, 95% CI 75.7% to 99.1%) who completed the 12-month angiographic follow-up. The primary safety endpoint of stroke occurred in one patient (3.3%), who made a complete clinical recovery at discharge. There were no neurological deaths.ConclusionThe Neuroform Atlas stent in conjunction with coils demonstrated a high rate of complete aneurysm occlusion at 12-month angiographic follow-up, with an improved safety profile in the HDE cohort.Clinical trialgov registration numberNCT0234058;Results.

Purpose: To compare the technical performance and outcomes of Solitaire and Neuroform stents for treatment of intracranial bifurcation aneurysms (IBAs). Methods: IBAs treated by stent-assisted coiling using a Solitaire or Neuroform stent between October 2010 and December 2019 were retrospectively evaluated. Patient demographics, aneurysm information, treatment technique, periprocedural and device-related complications, parent artery angle change, along with initial and follow-up angiographic results were analyzed. Results: One hundred twenty-one patients with 121 IBAs treated with Solitaire (n = 101) or Neuroform (n = 20) stent-assisted coiling were included. Aneurysm size, thrombotic and hemorrhagic complication rate, initial occlusion rate and in-stent stenosis between the two cohorts were not significantly different. Aneurysm location was significantly different between the two groups (p = 0.032). Jailing technique rate for coiling was significantly higher in the Solitaire than the Neuroform group (70.3% vs. 35.0%, p < 0.01). Follow-up DSA demonstrated a significantly lower recurrence rate for the Solitaire cohort (2.9% vs. 22.2%, p = 0.016). Parent artery angle changes, immediately post-operative and on follow-up were significantly greater in the Solitaire stent group (p < 0.05). Conclusions: For intracranial bifurcation aneurysms, Solitaire stent-assisted coiling achieved a significantly lower recurrence rate and induced more favorable parent artery angular remodeling than Neuroform stenting. [ABSTRACT FROM AUTHOR]

Background: Percutaneous transluminal angioplasty and stenting with the Wingspan stent has proven safe and effective in patients with middle cerebral artery stenosis (MCAS), but the off-label use of the Neuroform stent might be an alternative treatment. This study aimed to compare the safety and effectiveness of the above two intracranial stents in patients with MCAS.Methods: We retrospectively analyzed consecutive patients with symptomatic MCAS who had been treated with the Neuroform EZ or the Wingspan stent. A propensity score was generated to control for differences in baseline characteristics. The endpoints were the rate of peri-procedural complications within 30 days after stenting, the in-stent restenosis rate, and any target-vessel-related stroke or deaths during follow-up.Results: After matching for propensity score, the peri-procedural complication rate in the Wingspan group was 7.4% compared with 5.6% in the Neuroform group (p = 1.00), while the follow-up in-stent restenosis rates were 23.3 vs. 14.3%, respectively (p = 0.41). In the restenosis group, the patients tended to be younger (p < 0.01) and the degree of artery stenosis before stenting was higher (p < 0.01).Conclusion: This study indicated that in patients with symptomatic MCAS, Neuroform EZ stents are an alternative to Wingspan. Moreover, younger age and higher degree of artery stenosis before stenting might be a risk factor of in-stent restenosis.

Aneurysms located in the posterior inferior cerebellar artery (PICA) are not a majority of the intracranial aneurysms cases. Many challenges were addressed in the endovascular procedure to treat the disease. The authors have successfully diagnosed and treated a ruptured proximal PICA aneurysm. However, digital subtraction angiography showed acute thrombosis in the vertebral artery in the procedure, which probably could be an acute in-stent thrombosis. The tirofiban hydrochloride injection was subjected through a microcatheter, and then, the second Neuroform EZ stent was planted. In the 6-month follow-up, no recurrence of the aneurysm and complete patency of the right PICA at the site of aneurysm formation were found. We believe that the treatment of PICA aneurysms with Neuroform EZ stents could get a favorable result. Combination of tirofiban hydrochloride and Neuroform EZ stent could be an effective approach in treating acute thrombotic complications.

Introduction: One of the popular treatment strategies for complex cerebral aneurysms with wide necks or low dome-to-neck ratios is stent-assisted coiling. The most widely used intracranial stents for stent-assisted coiling are Neuroform (NF) and Enterprise (EP) stents. The purposes of this study are to review the recent literature of the past 5 years to compare outcomes between the EP and NF stent-assist coiling systems so as to comment on the safety, efficacy, complications, and recurrence rate of stent-assisted coiling in general. Methods: PubMed was used to search for all published literature of NF or EP stent-assisted coiling of unruptured cerebral aneurysms from January 2014 to August 2019 with the search terms of "Enterprise stent-assisted coiling," "Neuroform stent," and "Neuroform vs. Enterprise stent." Results: Twenty two publications met the inclusion criteria which encompass 1764 patients and 1873 aneurysms. Out of these 1873 aneurysms, 1007 aneurysms were treated with EP stent and 866 aneurysms were treated with NF stent. The overall outcome was low rates of thromboembolic complications (4.37%) and intracranial hemorrhage (1.13%), low permanent morbidity (1.70%) and mortality (0.40%), and lower rate of recanalization (11%). Data analysis shows an overall higher rate of complication and recurrence of aneurysm and lower overall rate of aneurysmal occlusion in the patients where EP stent was used in comparison to NF stent. However, this difference was not statistically significant. Conclusions: The review of two stent-assisted coiling devices using EP and NF stents including 1873 aneurysms in 1764 patients revealed that overall, it is safe and effective with comparable outcomes. [ABSTRACT FROM AUTHOR]

Background Intracranial wide-neck aneurysms at the arterial bifurcations, especially in the aneurysms where the bifurcating branches emanate directly from the base of the aneurysm, have been particularly difficult on which to perform endovascular treatment. The ‘Y’-configuration, double stent-assisted coil embolization is an option for the treatment of these difficult aneurysms, allowing the closure of the aneurysm, preserving the parent arteries. Material and methods In a nine-year period, 546 intracranial aneurysms in 493 patients were treated at our center by endovascular approach. We have reviewed the medical records and arteriographies from November 2007 to January 2017 of 45 patients who were treated using ‘Y’-configuration double Neuroform® stent-assisted coil embolization.Results All patients were successfully treated. The location of the aneurysms were: middle cerebral artery (MCA) 20 (44.4%), anterior communicating artery (AComA) 17 (37.7%), basilar four (8.9%), internal carotid artery (ICA) bifurcation three (6.6%) and posterior communicating artery (PComA) one (2.2%). The mRS at hospital discharge was: mRS 0: 42 (93.3%), mRS 1: 1 (2.2%), mRS 2: 1 (2.2%) and mRS 5: 1 (2.2%). The Modified Raymond-Roy Occlusion Classification, in the control at six months, was: Class I: 41 (91.1%), Class II: 2 (4.4%), Class IIIa: 1 (2.2%) and Class IIIb: 1 (2.2%). Forty-four (97.8%) patients had a good outcome (mRS < 2) at six months. One (2.2%) patient had a poor outcome (mRS > 2) at six months that was due to sequelae of SAH. There was no mortality at six months. Conclusions This technique is safe and effective for the endovascular treatment of difficult wide-neck bifurcation aneurysms, allowing the stable closure of the aneurysm, preserving the parent arteries. [ABSTRACT FROM AUTHOR]

The Neuroform EZ Stent System is a fourth generation intracranial aneurysm stent that utilizes an integrated navigation guidewire. While designed to facilitate stent delivery, the guidewire can rarely impede proper positioning of the stent. In this technical case report, severing the guidewire from the stent delivery system with surgical scissors was required for successful stent implantation.

Recanalization of acute large artery occlusions is a strong predictor of good outcome. The development of thrombectomy devices resulted in a significant improvement in recanalization rates compared to thrombolytics alone. However, clinical trials and registries with these thrombectomy devices in acute ischemic stroke (AIS) have shown recanalization rates in the range of 40-81%. The last decade has seen the development of nickel titanium self-expandable stents (SES). These stents, in contrast to balloon-mounted stents, allow better navigability and deployment in tortuous vessels and therefore are optimal for the cerebral circulation. SES were initially used for stent-assisted coil embolization of intracranial aneurysms and for treatment of intracranial stenosis. However, a few authors have recently reported feasibility of deployment of SES in AIS. The use of these devices yielded higher recanalization rates compared to traditional thrombectomy devices. Encouraged by these results, retrievable SES systems have been recently used in AIS. These devices offer the advantage of resheathing and retrieving of the stent even after full deployment. Some of these stents can also be detached in case permanent stent placement is needed. Retrievable SES are being used in Europe and currently tested in clinical trials in the United States. We review the recent literature in the use of stents for the treatment of AIS secondary to large vessel occlusion.

Objective: To present detailed results of our treatment experience in using Neuroform Stent-Assisted Coil embolization to treat complex cerebral aneurysms over 3-year period, emphasizing on the technical difficulties, procedure-related complications, and to evaluate midterm results. Methods: Patients underwent Neuroform stent-assisted coil embolization were registered in a database. We assessed patients’ history, aneurysm morphology, indications for stenting, and technical details of the procedures, complications and midterm follow-up data. Results: This study included twenty-six patients with 39 aneurysms. A total of 32 of 39 aneurysms were treated by Neuroform stent-assisted embolization (SAC). Three anuerysms stented without coiling, 2 aneurysms coiled without stenting and 2 aneuysms surgically clipped. The indications for use included broad-necked aneurysms (n = 28), giant or large aneurysms (n = 6), and fusiform aneurysms (n = 5). Of the 32 aneurysms treated by Neuroform SAC, we achieved complete (100%) and near complete (> 95%) occlusion in 27 aneurysms, and Partial (< 95%) occlusion in 5 aneurysms. Follow-up angiographic data avialble in 22 of 32 aneurysms treated by Neuroform SAC (68.7%) (average follow-up, 12 mo; range 4–24 mo) demonstrating recanalization in 3 aneurysms (13.6%), and stable occlusion in 19 aneurysms (86.4%). No delayed progressive embolization or in-stent stenosis observed. Conclusion: Neuroform microstent system led to a significant evolution in the endovascular treatment of complex intracranial aneurysms. Our results and midterm follow-up showed Neuroform stent-assisted coil embolization is safe and effective technique in the treatment of complex cerebral aneurysms. Although, the clinically significant complications are uncommon and the evaluation at midterm follow-up is encouraging, further studies needed to assess the long-term stability and durability of the stent.

Purpose: To compare the mid-term follow-up angiographic findings in distal internal carotid artery (ICA) aneurysms treated by stent-assisted coil embolization using the Enterprise or Neuroform stent. Materials and Methods: We included 68 patients with 70 aneurysms: 31 cases with Enterprise and 39 cases with Neuroform. Inclusion criteria were 1) location of the stent within the distal ICA, including the carotid siphon; 2) follow-up angiogram after > 6 months, and 3) single use of the stent for 1 parent artery. Results: The patients' mean age was 54.9 years (16 male and 52 female). Mean follow-up duration was 9.1 months. At follow-up, there were intraluminal filling defects of the parent artery in 19.4% of the Enterprise group and no filling defect in the Neuroform group. There was no significant in-stent stenosis in either group. Straightening of the parent artery was seen in 35.5% of the Enterprise group and 20.5% of the Neuroform group. Two Enterprise cases showed delayed migration. Conclusion: The Enterprise showed statistically significant intraluminal filling defects of the parent artery compared with the Neuroform. The rates of significant instent stenosis and straightening of the parent artery were not significantly different between the Enterprise and the Neuroform groups. [ABSTRACT FROM AUTHOR]

Objective : An open cell stent system may offer better apposition of cell struts to vessel wall than a closed cell stent system in acute vasculature. The purpose of this study was to evaluate the feasibility of coiling using the jailing technique with the Neuroform EZ stent system. Methods : The jailing technique using the open-cell stent system of the Neuroform EZ stent was planned in 22 consecutive patients with 22 cerebral aneurysms. We retrospectively evaluated the technical success of the jailing technique and the occurrence of interference between two microcatheters as well as the factors influencing this interference. Results : The jailing technique was successful in 19/22 patients (86.4%), and interference between two microcatheters occurred in 6/21 (28.6%). The jailing technique failed in 3/22 patients, with problems that included failure of the stent delivery system to advance into the positioned microcatheter in one, interference between the microcatheters during the advancement of the stent delivery system in one, and failure of microcatheter insertion into the aneurysm sac in the remaining patient. Interference between the two microcatheters developed during the advance of the stent delivery system into the positioned microcatheter in all cases. One factor that influences interference between two microcatheters more than expected by chance is the carotid siphon angle (p = 0.019). Conclusion : The acuteness of the carotid siphon angle influences the interference between two microcatheters. Therefore, the jailing technique using the Neuroform EZ stent should be performed carefully in cerebral aneurysms with an acute carotid siphon angle because the procedure may possibly fail. [ABSTRACT FROM AUTHOR]

The Neuroform EZ Stent System is a fourth generation intracranial aneurysm stent that utilizes an integrated navigation guidewire. While designed to facilitate stent delivery, the guidewire can rarely impede proper positioning of the stent. In this technical case report, severing the guidewire from the stent delivery system with surgical scissors was required for successful stent implantation. [ABSTRACT FROM AUTHOR]

A 43-year-old woman attended for stent assisted coiling. A Neuroform 30 × 4.5 mm stent had been successfully placed over the left periophthalmic aneurysm. During the coiling the first coil migrated through the crowns in the stent, lodging at the MCA bifurcation. We believe that the coil herniated through the overlying stent due to the carotid siphon curvature and the open cell design. Furthermore the distal markers of the stent impeded coil extraction with a MERCI device. [ABSTRACT FROM AUTHOR]

Stenting as adjuvant therapy for the coiling of acutely ruptured aneurysms remains controversial due to the necessity of anticoagulation and antiplatelet medications. We report our experience using the Neuroform stent in the management of 41 aneurysms in 40 patients over a period of three years. For aneurysms whose open surgical risk remains excessive with a morphology that would preclude complete embolization, the risks of stenting may be warranted. [ABSTRACT FROM AUTHOR]

The purpose of this study was to evaluate and report our anatomic results and complications associated with stent-assisted coil embolization of intracranial aneurysms using the Neuroform stent. From September 2003 to August 2007, 127 consecutive patients (ruptured 50, 39.4%; unruptured 77, 60.6%) underwent 129 stent-assisted coil embolization procedures to treat 136 aneurysms at our institution. Anatomic results at follow-up, procedure-related complications, and morbidity/mortality were retrospectively reviewed.Stent deployment was successful in 128 out of 129 procedures (99.2%). Forty-seven patients presented with 53 procedure-related complications (37.0%, 47/127). Thromboembolic events (n = 17, 13.4%) were the most common complications, followed by intraoperative rupture (n = 8, 6.3%), coil herniation (n = 5, 3.9%), and postoperative rupture (n = 4, 3.1%). For thromboembolic events, acute intra-procedural in-stent thromboses were observed in two patients and subacute or delayed in-stent thromboses in three patients. Overall mortality rate was 16.5% (21/127) and procedure-related morbidity and mortality rates were 5.5% (7/127) and 8.7% (11/127) retrospectively. Patients with poor grade subarachnoid hemorrhage (Hunt and Hess grade IV or V; 25/127, 19.7%) exhibited 56% (14/25) overall mortality rate and 24% (6/25) procedure-related mortality rate. Immediate angiographic results showed complete occlusion in 31.7% of aneurysms, near-complete occlusion in 45.5%, and partial occlusion in 22.8%. Sixty nine patients in 70 procedures with 77 aneurysms underwent angiographic follow-up at six months or later. Mean follow-up period was 13.7 months (6 to 45 months). Complete occlusion was observed in 57 aneurysms (74.0%) and significant in-stent stenosis was not found.Thromboembolism and intra/postoperative aneurysm ruptures were the most common complications and the main causes of procedure-related morbidity and mortality. Patients with poor grade subarachnoid hemorrhage showed poor clinical outcomes. Since most complications were induced by stent manipulation and deployment, it is mandatory to utilize these devices selectively and cautiously. While the follow-up angiographic results are promising, further studies are essential to evaluate safety, efficacy, and durability of the Neuroform stent. [ABSTRACT FROM AUTHOR]