ABo and TW conceived the idea for the study and interpreted the data of work. Demographics, baseline data, and procedural characteristics were summarized and reported as mean±SD and range for continuous variables. The majority of aneurysms were <10 mm (n=117, 62.9%). Talk with your doctor and family members or friends about deciding to join a study. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04267393, The new site is coming soon - go to the modernized. 103/2018; ethics committee University of Regensburg, Ref-No. See this image and copyright information in PMC. To assess the safety and angiographic efficacy of the p64 flow modulation device. government site. 9 recently published a retrospective, single-center series of 530 patients harboring 617 unruptured saccular aneurysms (or those treated >30 days post-rupture), located in the anterior circulation and treated with at least one p64 FMD. Comparison of intra-aneurysmal flow modification using optical flow imaging to evaluate the performance of Evolve and Pipeline flow diverting stents, Variable porosity of the Pipeline embolization device in straight and curved vessels: a guide for optimal deployment strategy. Received 2021 May 28; Accepted 2021 Sep 21. In the last patient, death occurred 3 weeks postprocedure, secondary to a subdural hematoma that was thought to be caused by antiplatelet medication. The majority of aneurysms (68.9%) were small (<10 mm) and wide-necked (96.1%). -, Cancelliere NM, Nicholson P, Radovanovic I, et al. Investigators were required to report all adverse events and serious adverse events. Intrasaccular neck-bridging: A technical note on Nautilus-assisted coiling of wide-necked cerebral aneurysms. Burdenko" of the Ministry of Health of the Russian Federation, Ref-No. 2017 Jan;9(1):70-76. doi: 10.1136/neurintsurg-2016-012502. Prot. Two core laboratory readers performed a review of all patients independently from each other. Unable to load your collection due to an error, Unable to load your delegates due to an error. Department of Vascular Neurosurgery, Russian Polenov Neurosurgical Institute, Federal Almazov North West Medical Research Centre, St Petersburg, Russian Federation, 9 Aguilar Pérez M, Bhogal P, Henkes E, et al.. In-stent stenosis after p64 flow diverter treatment, The p64 flow diverter-mid-term and long-term results from a single center, Endovascular treatment of unruptured aneurysms, Pipeline for uncoilable or failed aneurysms: results from a multicenter clinical trial, International retrospective study of the Pipeline embolization device: a multicenter aneurysm treatment study, The Pipeline embolization device for the intracranial treatment of aneurysms trial, Prospective study on embolization of intracranial aneurysms with the Pipeline device: the PREMIER study 1 year results, SAFE study (safety and efficacy analysis of FRED embolic device in aneurysm treatment): 1-year clinical and anatomical results, Derivo embolization device in the treatment of unruptured intracranial aneurysms: a prospective multicenter study, Surpass flow diverter in the treatment of intracranial aneurysms: a prospective multicenter study. Accessibility 2023 Apr;29(2):211-213. doi: 10.1177/15910199221082443. Baseline aneurysm characteristics are summarized in table 1. 2019/PO/011 Vs. rif. Mit Helios finden Sie . 0800 633 4946. Objective: To assess the safety and angiographic efficacy of the p64 flow modulation device. The majority of cases (5.5%, n=19/343) represented mild stenosis with only a single case of severe stenosis (≥75%). Department of Neuroradiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK, 17 Any degree of in-stent stenosis was seen in 8.7% of patients at the second follow-up (n=30/343). p64 flow modulation device in the treatment of intracranial aneurysms: initial experience and technical aspects. This has been acknowledged as several flow diverter stents were available in most of the participating centers and flow diverter selection was left to the treating physician. Background: Unity Health-White County Medical Center, Veterans Health Care System of the Ozarks, Keck Medical Center of USC Beverly Hills -, Kaiser Permanente Southern California - Los Angeles Medical Center, Loma Linda University Medical Center – Murrieta –, Kaiser Permanente, San Diego Medical Center, Memorial Health University Medical Center, Presence Saints Mary and Elizabeth Medical Center, The Children's Hospital of Illinois (CHOI) and St. Jude Midwest Affiliate at OSF Saint Francis, Indiana University Health Bedford Hospital, Indiana University Health Bloomington Hospital, Riley Hospital for Children at Indiana University Health North Hospital, Indiana University Health Saxony Hospital, Indiana University Health Frankfort Hospital, Indiana University Health Blackford Hospital, Indiana University Health Arnett Hospital, Indiana University Health Arnett Hospital Hospice, Indiana University Health White Memorial Hospital, Indiana University Health Tipton Hospital, Heart Hospital and Harper Specialty Center, University of Minnesota Medical Center, East Bank. Successful flow-diverter delivery was achieved in 161 patients with 186 aneurysms (98%). Briganti F, Leone G, Marseglia M, et al.. p64 flow modulation device in the treatment of intracranial aneurysms: initial experience and technical aspects. The most common locations were the cavernous and supraclinoid segments (83.5%) of the internal carotid artery. A special focus on primary safety and efficacy endpoints is summarized in table 2. All of those minor strokes and silent infarctions occurred in the same territory of the treated vessel, probably thromboembolic in origin. Most aneurysms had not been previously treated (86.9%). Briganti F, Leone G, Ugga L, Marseglia M, Macera A, Manto A, Delehaye L, Resta M, Resta M, Burdi N, Nuzzi NP, Divenuto I, Caranci F, Muto M, Solari D, Cappabianca P, Maiuri F. J Neurointerv Surg. Epub 2016 Jul 20. In total, the core laboratory assessment determined that 23 patients had an intraprocedural complication, with the most common being thromboembolism (n=17/420, 4.0%). See: {"type":"clinical-trial","attrs":{"text":"NCT02600364","term_id":"NCT02600364"}}, A new endoluminal, flow-disrupting device for treatment of saccular aneurysms, Cellular mechanisms of aneurysm occlusion after treatment with a flow diverter. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. aneurysm; flow diverter; stent. Azienda Ospedaliera Ospedale di Circolo di Busto Arsizio, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona -, A.O.U. LP declares consulting services for Balt, Cerus Endovascular, Microvention, Perflow, phenox, and Vesalio. Ciudad de México-UNAM, Hospital General Dr. Manuel Gea González. The p64 flow modulation device was used to treat anterior circulation aneurysms between . Ns. National Library of Medicine The mean aneurysm size in Diversion-p64 was 6.99±5.28 mm, which is comparable to the aforementioned studies. Kallmes DF, Ding YH, Dai D, et al. Diversion-p64 is the largest prospective study on the p64 FMD. The core laboratory reviewed the image material of all procedures, and any complication depicted on imaging that was not yet known from event reporting by the investigators was additionally presented to the CEC for adjudication. 0800-Medizin. 2022 Jun 6;11(11):3230. doi: 10.3390/jcm11113230. ABSTRACT No. Inclusion in an NLM database does not imply endorsement of, or agreement with, See rights and permissions. J Clin Med. Revision and Analysis Phenox - Protocol. Safety and efficacy results of Diversion-p64 in comparison with similar prospective non-randomized studies involving other flow diverters. A satisfactory position of the device (B) was confirmed on unsubtracted images (C). Department of Neuroradiology, Hôpital Maison Blanche, Reims, France, 15 These therapies are available at Helios Klinikum Emil von Behring. Of all the patients who had a minor stroke (n=24), five were clinically silent (20.8%) and 12 had transient clinical symptoms that completely resolved (50%). In total there were two aneurysm growths, one seen at the first follow-up (0.3%) and one seen at the second follow-up (0.3%). Federal government websites often end in .gov or .mil. Although a substantial number of patients were lost between the first (6 months; 413/420, 93.3%) and last safety follow-up (12 months; 372/420, 88.6%), only a single minor stroke was recorded within this time frame. Data are available upon reasonable request. ABo and PS agreed to be accountable for all aspects of the work and ensured that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The use of flow diversion to treat intracranial aneurysms has increased in recent years. Mercy Health - St. Elizabeth Boardman Hospital. The primary safety endpoint was the incidence of major stroke or neurologic death at 3-6 months, with the primary efficacy endpoint being complete aneurysm occlusion (Raymond-Roy Occlusion Classification 1) on follow-up angiography. TG serves as a proctor for phenox. 16-171_2-103; ethics committee of the Chamber of Physicians of Westphalia-Lippe and the Westphalian Wilhelms University, Ref-No. Furthermore, the majority of aneurysms included in the study were <10 mm, although most aneurysms were wide-necked. Departamento de Neurociencias, ENERI, Clínica La Sagrada Familia, Buenos Aires, Argentina, 4 Proximally, the 64 wires form eight bundles each of which has a proximal radiopaque marker. sharing sensitive information, make sure you’re on a federal It can be concluded that the device has a high efficacy and excellent safety profile that is comparable to other devices. . HH is a co-founder and shareholder of phenox, femtos, and CONTARA; serves as proctor and consultant for phenox; and declares personal financial interest in Johnson & Johnson and Penumbra. Mercy Health - St. Joseph Warren Hospital. University Hospitals Richmond Medical Center. San Giovanni di Dio Ruggi d'Aragona, Azienda Ospedaliera Universitaria di Ferrara Arcispedale Sant'Anna, Azienda ospedaliera - Universitaria Policlinico di Modena, Azienda Ospedaliero- Universitaria di Parma, Azienda Ospedaliero-Universitaria Santa Maria della Misericordia, Azienda Ospedaliera San Giovanni Addolorata, IRCCS-Azienda Ospedaliera Universitaria "San Martino", Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Azienda Ospedaliera "Maggiore della Carità", Azienda Ospedaliera-Universitaria San Luigi Gonzaga, Azienda Ospedaliera Universitaria di Cagliari, Azienda Ospedaliera Universitaria di Sassari, Azienda Ospedaliero Universitaria "Policlinico - Vittorio Emanuele", A.O.U. LSt declares personal financial interest for Medtronic and Terumo. In one case, a type A aortic dissection was discovered in the early postoperative period that resulted in myocardial infarction and death. Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Proportion of participants who achieve ≥ 1 stage improvement in liver fibrosis (NASH CRN Fibrosis Score) [ Time Frame: At 12 weeks ], Proportion of participants with ≥ 1 stage improvement in liver fibrosis with no increase of the NAS [NAFLD (Nonalcoholic fatty liver disease) Activity Score] by ≥ 1 point [ Time Frame: At 12 weeks ], Proportion of participants with ≥ 2 stage improvement in liver fibrosis score (NASH CRN Fibrosis Score) [ Time Frame: At 12 weeks ], Proportion of participants with ≥ 1 stage improvement in modified Ishak liver fibrosis score [ Time Frame: At 12 weeks ], Proportion of participants with ≥ 2 stage improvement in modified Ishak liver fibrosis score [ Time Frame: At 12 weeks ], Change from baseline in collagen proportionate area (CPA) [ Time Frame: At 12 weeks ], Incidence of Adverse Events (AEs) [ Time Frame: Up to week 36 ], Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to week 36 ], Incidence of clinically significant changes in clinical laboratory values: Hematology tests [ Time Frame: Up to week 36 ], Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests [ Time Frame: Up to week 36 ], Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests [ Time Frame: Up to week 36 ], Incidence of clinically significant changes in vital signs: Body temperature [ Time Frame: Up to week 36 ], Incidence of clinically significant changes in vital signs: Respiratory rate [ Time Frame: Up to week 36 ], Incidence of clinically significant changes in vital signs: Blood pressure [ Time Frame: Up to week 36 ], Incidence of clinically significant changes in vital signs: Heart rate [ Time Frame: Up to week 36 ], Incidence of clinically significant changes in electrocardiogram (ECG) parameters: Mean heart rate [ Time Frame: Up to week 36 ], Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval [ Time Frame: Up to week 36 ], Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval [ Time Frame: Up to week 36 ], Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval [ Time Frame: Up to week 36 ], Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcB interval [ Time Frame: Up to week 36 ], Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval [ Time Frame: Up to week 36 ], Incidence of clinically significant changes in physical examination [ Time Frame: Up to week 36 ], Change from baseline in bone mineral density (BMD), as measured by dual-energy x-ray absorptiometry (DXA) scan [ Time Frame: Up to week 36 ], Plasma concentrations of components of BMS-986263 for injection [ Time Frame: Day 1 to week 12 ], Participants with liver biopsy fibrosis score stage 4 (NASH CRN) performed within 12 months, Men and women must agree to follow methods of contraception, Worsening liver disease or any disease might compromise participant safety in the opinion of the investigator, Known immunocompromised status or any disease or condition which might compromise participant safety, Clinically relevant abnormal physical examination, vital signs, ECG, or clinical laboratory tests. Very small aneurysms (<4 mm) accounted for 31.4% of aneurysms. The Algerian Ministry of Health, Population and Hospital Reform maintains 15 public university teaching hospital centers (French: Centre Hospitalo-Universitaire or CHU) with 13,755 beds and one public university hospital (EHU) with 773 beds.[1]. Permanent neurologic morbidity and mortality were 6% and 2.7%, respectively. Mercy Health - St. Vincent Medical Center. All core laboratory members are licensed and practicing interventional neuroradiologists, each with over 10 years of experience in interventional neuroradiology and experience as core laboratory reader in previous studies. 0800 633 4946. A total of 420 patients met all eligibility criteria and underwent treatment with the p64 FMD and constitute the per-protocol group on which this analysis has been performed. There is no long-term follow-up and heterogeneous use of antiplatelet medications and their duration. At the second angiographic follow-up (mean 375±73 days), available for 343 patients (81.7%), complete aneurysm occlusion was seen in 287 (83.7%) patients. Die Experten des Lungenzentrums München West in der Helios Klinik München West sind auf die Diagnostik und interdisziplinäre Behandlung von Lungenkrankheiten spezialisiert Die Lungenspezialisten im Münchner Westen Unsere Lungenspezialisten in München behandeln akute, sowie chronische Erkrankungen der Lunge und der Atemwege. Contributors: ABo, MAP, HH, PL, CB, GG, SS, AS, LSt, FT, AP, CR, A-PN, XB, CL, ABe, LP, MM, TG, AC, JK, CWa, MDO, LSp, FC, SY, PK, NPN, SD, CWe acquired data for analysis. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. With . To assess the safety and angiographic efficacy of the p64 flow modulation device. The p64 flow modulation device was used to treat anterior circulation aneurysms between December 2015 and January 2019. Disclaimer. PK serves as proctor and consultant for phenox and received travel and meeting expenses from phenox. Funding: This study was funded by phenox GmbH, Bochum (Germany). The development and introduction of flow diverter stents into clinical practice was a pivotal moment in the treatment of cerebral aneurysms.1 2, It is now understood that devices constructed with an increased number of wires have a greater flow diverting effect3 and a lower variance in the flow diverting effect when there are changes in the caliber of the underlying vessel or in curved vessels.4. *Previously flow diverted with p64 flow modulatiion device. The study protocol and the informed consent form were submitted to the local ethics committee for favourable opinion. No delayed aneurysmal ruptures or parenchymal hematomas were seen. An official website of the United States government. Adjunctive coiling was performed in 59/420 (14.0%) cases. The main limitations of Diversion-p64 are the non-randomized nature and the lack of a control arm with inherent risk of selection bias. For each of them, the narrative will be restricted to the main findings of the study. 10.1136/neurintsurg-2019-015696 . Diakonissenkrankenhaus Karlsruhe-Rüppurr, Theresienkrankenhaus und St. Hedwig-Klinik Mannheim (. Before There were four aneurysm recanalizations (blood flow into the aneurysm increased compared with previous visit), two at the first follow-up (0.6%) and two at the second follow-up (0.6%). In comparison with these previous studies, the results from Diversion-p64 are favorable. Comparison of intra-aneurysmal flow modification using optical flow imaging to evaluate the performance of Evolve and Pipeline flow diverting stents. The in-stent stenosis rate in Diversion-p64 is also comparable to rates reported for other devices. Epub 2017 Apr 24. Department of Radiology and Neuroradiology, Klinikum Vest GmbH Behandlungszentrum Knappschaftskrankenhaus Recklinghausen, Recklinghausen, Nordrhein-Westfalen, Germany, 13 Most of aneurysms were asymptomatic (77.4%) and found incidentally (66.4%). Nationales Centrum für Tumorerkrankungen. Policlinico Paolo Giaccone-Dep. Inclusion criteria allowed enrollment of unruptured aneurysms of any size located within either the anterior or posterior circulation in patients with a mRS score of ≤1. The most common aneurysm locations were paraophthalmic (59.3%) and posterior communicating artery (16.9%). Before placement of the p64 FMD, patients underwent a neurological assessment using the modified Rankin Scale (mRS) and National Institutes Health Stroke Scale (NIHSS). Based on this, a sample size of 348 patients completing the 3–6 months' follow-up was calculated to provide a power of 80% to meet the primary safety endpoint. Recruiting sites had to be familiar with the p64 FMD. A total of 420 patients met the eligibility criteria and underwent treatment with the p64 flow modulation device (mean age 55±12.0 years, 86.2% female). Control angiography performed at 4 months postprocedure showed complete occlusion of the aneurysm (E), that was confirmed on delayed angiography performed 10 months post-rocedure (F). 59350/2017/114; ethic committee of Clínica La Sagrada Familia, Ref-No. 19 recently published results from a prospective, international, multicenter trial assessing the Derivo embolization device (DED, Acandis, Pforzheim, Germany). Endovascular treatment of previously clipped aneurysms: continued evolution of hybrid neurosurgery. Hier gelangen Sie direkt zu unseren Corona-Informationen aktuellen Nachrichten Klinikkontakten Unauthorized use of these marks is strictly prohibited. Neuroradiology, Regionalny Szpital Specjalistyczny im dr Wl Bieganskiego, Grudziadz, Poland, 20 Choosing to participate in a study is an important personal decision. Medical history and concomitant medications were recorded. The .gov means it’s official. LSp is a consultant for Balt, Medtronic, Microvention, phenox, and Stryker and also declares support for Balt, Medtronic, Microvention, and Stryker outside of this work. The p64 flow modulation device was used to treat anterior circulation aneurysms between December 2015 and January 2019. Intraoperative vessel perforation occurred in two patients and intraoperative aneurysm perforation in one patient. © Author(s) (or their employer(s)) 2022. The site is secure. The main hypothesis of the study was that the rate of neurological death and major stroke within 3–6 months after treatment with the p64 FMD in patients with aneurysms in the anterior circulation was not inferior to the weighted mean rate of neurological death and major stroke within 6 months from three relevant studies at the time of study design and recruitment. Sirakova K, Penkov M, Matanov S, Minkin K, Ninov K, Hadzhiyanev A, Karakostov V, Ivanova I, Sirakov S. Front Neurol. Keywords: Psychiatrische Universitätsklinik Erlangen, Helios Klinikum München West - Klinikum München Pasing (. Angiographic aneurysm occlusion rates were also very favorable, with 83.7% of aneurysms occluded at the second angiographic follow-up, and 86% achieving adequate occlusion. We would like to acknowledge the work of Lena Vadder, phenox GmbH. Berufsgenossenschaftliche Unfallklinik Ludwigshafen, University General Hospital of Heraklion "PAGNI" -, University General Hospital of Thessaloniki "AHEPA" -, Gleneagles Hong Kong Hospital - Li Ka Shing Faculty of Medicine, The University of Hong Kong, CUHK Medical Centre - CUHK Faculty of Medicine, United Christian Hospital - CUHK Faculty of Medicine, Azienda Ospedaliera Universitaria Ospedali Riuniti di Foggia -, Azienda ospedaliero-universitaria "Vito Fazzi"- University of Salento, Lecce, Ospedale "Santissima Annunziata"- University of Bari, Taranto, Ente ecclesiastico Ospedale regionale "Francesco Miulli"- LUM University, Acquaviva delle Fonti, Azienda ospedaliera "Cardinale Giovanni Panico"- University of Bari, Tricase, Ospedale "Perrino"- University of Bari, Brindisi, Azienda Ospedaliero – Universitaria Mater Domini -, Istituto Scientifico di Riabilitazione di Telese Terme, Nuovo Ospedale Civile S. Agostino-Estense -, Policlinico Universitario Campus Bío-Medico -, Azienda Ospedaliera Papa Giovanni XXIII -, IRCCS San Giovanni di Dio Fatebenefratelli, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Azienda Socio Sanitaria Territoriale del Garda. 10.1161/STROKEAHA.106.479576 The majority of saccular aneurysms (64%) were small (<7 mm) and 61.1% of aneurysm had a wide-neck (dome to neck ratio <1.5). Neuroradiologische Klinik, Klinikum Stuttgart, Stuttgart, Baden-Württemberg, Germany, 3 University Hospitals St. John Medical Center. Fischer S, Aguilar-Pérez M, Henkes E, et al.. Similar rates of in-stent stenosis have been reported for the FRED (7.6%)23 and the DED (6.6%).24. PK serves as proctor and consultant for phenox and received travel and meeting expenses from phenox. Bookshelf The results of this study demonstrate that the device has a high efficacy and carries a low rate of mortality and permanent morbidity.