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XIX Symposium Neuroradiologicum, Bologna, Italy, 4-9 October 2010

Mul ticenter Prospective Study on the S afety and E fficacy of the N euroform 3 TM Stent for A neurysm T reatment ( S.E.N.A.T. Study): Per protocol Analysis. Alessandra Biondi 1 , Alain Bonaf é 2 and the French study Investigators.

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XIX Symposium Neuroradiologicum, Bologna, Italy, 4-9 October 2010

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  1. Multicenter Prospective Study on the Safety and Efficacy of the Neuroform3TM Stent for Aneurysm Treatment (S.E.N.A.T. Study): Per protocol Analysis Alessandra Biondi 1, Alain Bonafé 2 and the French study Investigators 1 Jean Minjoz Hospital, Besançon University, France 2 Gui de Chauliac Hospital, Montpellier University, France Study sponsorship provided by Boston Scientific France XIX Symposium Neuroradiologicum,Bologna, Italy, 4-9 October 2010

  2. Neuroform3TM Stent • Self-expanding nitinol stent • Specifically designed for the treatment of intracranial aneurysms by Stent-assisted Coiling.

  3. S.E.N.A.T Study Objectives To evaluate : • The morbi-mortality of Neuroform3TM stent-assisted coiling for the treatment of intracranial aneurysms @ 1 month and 12-18 month-FU • The anatomic results immediately after the procedure and @ 1 month and 12-18 month-FU (comparison of the anatomical stability of treatment with the initial occlusion rate) • The patency of the Neuroform3™stent • The adverse events with special focus on bleeding (for unruptured aneurysms) and re-bleeding (for ruptured aneurysms).

  4. Study Design • Prospective, multicenter, consecutive registry carried out in France from July 2008 to July 2009 • Intention-to treat, consecutive enrollment • Eleven French Centers • Inclusions and results controlled by an independent clinical monitoring lab.

  5. S.E.N.A.T.study • Inclusion criteria • Patient in whom a Neuroform3TM stent-assisted coiling procedure is planned for the treatment of an unruptured, ruptured or recurrent intracranial aneurysm • Patient > 18 year-old • Informed consent of the patient for collection of the data

  6. S.E.N.A.T.study • Exclusion criteria • Fusiform or dissecting aneurysms • Multiple aneurysms treated in the same session (except adjacent aneurysms treated by the same stent) • Vasospasm in aneurysmal SAH • Aneurysm associated with an AVM • Concomitant use of a different stent • Pregnancy or breast-feeding • Patients not allowing follow up • Patients under guardianship • Contra-indication to antiplatelet therapy

  7. Data collection and analysis • Data Analysis : Arianapharma. Statistician : Gaelle Piel • Independent monitoring : CLINACT (100% of the 1 month clinical Follow up) • Analysis of complications : adverse events • Independent Core lab • Electronic Data Collection System : KIKA Medical

  8. Patient Population • 123 patients enrolled • Protocol deviation: 7 patients (5.7%) • Multiple aneurysms : 4 • Severe vasospasm : 1 • No data after baseline : 1 • No stent needed to treat aneurysm : 1 • Total 116 patients per protocol

  9. Analyzed Population • 116 patients / 116 aneurysms included in the study • Female: 78 (67 %) Male: 38 (33 %) • Mean age: 52 years (range: 23 to 77 ys) • Unruptured aneurysms: 108 (93 %) • Ruptured aneurysms: 8 (7 %) • WFNS-1 (3 pts), WFNS-2 (3 pts), WFNS-5 (2 pts) • Anterior circulation: 104 (90 %) • Posterior circulation: 12 (10 %)

  10. Aneurysm location and size Aneurysm size 1-5 mm: 57 cases (49.1%) 6 -10 mm: 45 cases (38.8%) 11-24 mm: 13 cases (11.2%) ≥25 mm: 1 case (0.9%) Dome / neck ratio < 2: 106 cases (91.4%) ≥2: 10 cases (8.6%) • Location • Anterior circulation: 104 (89.6%) • Carotid-opht: 32 (27.6%) • MCA: 29 (25.0%) • PCom: 18 (15.5%); AChor: 4 (3.4%) • ACom: 10 (8.6%), Callosal: 2 (1.7%) • ICA bifurcation: 3 (2.6%) • Intracavernous ICA: 6 (5.2%) • Posterior Circulation: 12 (10.4%) • Basilar: 9 (7.8%) • SCA : 2 (1.7%) • PCA: 1 (0.9%)

  11. S.E.N.A.T.Study Stenting in 116 patients • 122 Stents used • 1 Stent: 110 patients (95 %) • 2 Stents: 6 patients (5 %) • 119 Stents deployed (97.5 %) • 1 Stent: 111 patients (95.7 %) • 2 Stents: 4 patients (3.4 %) • 0 Stent: 1 patient (0.9 %) • 3 Stents not deployed (2.5 %)

  12. Neuroform 3TMPerformances • Procedure Success Rate : 114 (98.2%) • Procedure discontinued: 2 • (1 coiling failure,1 stent dislodgment) • Stent Success Rate • First attempt stent delivery success: 110 (95.0%) • Second attempt stent delivery success: 115 (99.0%) • Double stenting : 4 (2 telescopic, 2 kissing) • Rescue stenting : 4 (3.4%)

  13. S.E.N.A.T.Study Immediate Angiographic Results 116 aneurysms Parent artery stenosis Non 113 (97.5 %) Yes 3 (2.5 %) Stent migration None 119 (100 %) Angiographic results Occlusion 74 (64 %) Neck remnant 26 (22 %) Residual aneurysm 16 (14 %)

  14. Complication Assessment – 18/116 patients • Procedural Complications : 9 (7.8%) • 1 Hemorrhage (Coil perforation) • 2 In-stent clot formation with thromboembolic complication • 6 Groin hematoma (1 retroperitoneal) • Post Procedural Complications : 8 (6.9%) • 4Thromboembolic complications(not linked to stenting) • 1 Remote IC hematoma • 1 Transient blindness • 2 Plavix ™* complications (allergy/ skin hematomas) • 1 month-FU Complication : 1 (0.8%) • 1 Oral lesions due to Plavix *Plavix is a registered trademark of BMS

  15. S.E.N.A.T.Study Complications – 18/116 patients • Complications linked to coiling: 4 (3.4%) • 1 hemorrhage due to coil perforation of the an. - No clinical consequence • 1 thromboembolic event due to coil herniation – No clinical consequence • 2 thromboembolic events – 1 permanent deficit & 1 transient deficit (coil stretching and failure of coil placement • Complications linked to medical treatment: 12 (10.3%) • 1 retroperitoneal hematoma - permanent deficit • 5 groin hematoma – no consequence • 1 remote IC hematoma – permanent deficit • 1 thromboembolic event due to Plavix discontinuation - no consequence • 1 transient blindness –no consequence • Complications linked to Stent: 2 (1.7%) • 2 thromboembolic events (1 permanent deficit ,1 no clinical manifestation)

  16. S.E.N.A.T.Study - Clinical Results Modified Rankin Scale @ 1 month after stenting 116 patients MRs before -108 patients MRs 0: 85 (79.4 %) MRs 1: 14 (13.1 %) MRs 2: 4 ( 3.7 %) MRs 3: 2 ( 1.9 %) MRs 4: 2 ( 1.9 %) 1 patient N.A. WFNS before - 8 patients WFNS 1: 3 (37.5 %) WFNS 2: 3 (37.5 %) WFNS 5: 2 ( 25 %) MRs @ 1 mo. -108 patients MRs 0: 87 (80.6 %) MRs 1: 12 (11.1 %) MRs 2: 5 ( 4.6 %) MRs 3: 1 ( 0.9 %) MRs 4: 3 ( 2.8 %) MRs @ 1 mo. - 8 patients MRs 0: 2 (25 %) MRs 1: 3 (37.5 %) MRs 4: 3 (37.5 %)

  17. S.E.N.A.T.Complications: 18/116 patients 1 month Follow UP • Without clinical consequences : 12 pts (10.3 %) • Transient morbidity: 1 pt (0.9 %) • Permanent morbidity: 5pts (4.3 %) • 3 out of 8 ruptured aneurysms (37.5%) • 2 out of 108 unruptured aneurysms (1.9%) • No mortality

  18. Conclusions Conclusions • The current study compares favorably to other series published on the use of the Neuroform™ Stent for the treatment of small and medium size IC aneurysms.¹ ² • Early results from this study support previous literature findings concludinguse of the Neuroform™Stent forthe treatment of unruptured intracranial aneurysms is safe.¹ ² • Our observations suggest that Neuroform™ Stent assisted coiling does not increase the risk of thromboembolic complications and the incidence of morbi-mortality in relation to coiling procedures performed without stenting.³ 1- A. Biondi et al. Neurosurgery 2007;61:460-469 2- D. Fiorella, et al. JNIS 2009: 1-7 3- HK. Park et al. AJNR 2005;26:506-514

  19. S.E.N.A.T.Study - Investigators • CHU Montpellier – A. Bonafé • CHU Pitié-Salpêtrière, Paris - A. Biondi, B. Jean, N. Sourour • CHU Lariboisière, Paris – E. Houdart, JP. Saint-Maurice • Fondation Rothschild, Paris – J. Moret, L. Spelle, M. Piotin, R. Blanc • CHU Bordeaux –J. Berge, X. Barreau • CHU Caen – P. Courtheoux • CHU Lille – X. Leclerc • CHU Limoges – C. Mounayer • CHU Nantes – H. Desal • CHU Nice – J. Sedat, Y. Chau • CHU Lyon – F. Turjiman

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