LB-007 Update on the saccular endovascular aneurysm lattice system interventional pivotal trial (SEAL TM IT)

Introduction

Pre-clinical animal and early feasibility human studies demonstrated promising results for treating ruptured and unruptured wide-neck intracranial aneurysms (IAs) with the novel Saccular Endovascular Aneurysm Lattice (SEAL™) system. The SEAL™ Interventional Pivotal IDE PMA Trial (SEAL™ IT) aims to evaluate the safety and effectiveness of the SEAL™ for saccular IAs. This ongoing, prospective, three-arm, multicenter trial will enroll 279 patients with wide-neck bifurcation (WNBA), sidewall (SW), or acutely ruptured IAs across 50 US sites.

Methods

Inclusion criteria include age 20-80 years, wide-neck saccular IA (2-19mm), and suitability for SEAL™ Intrasaccular Device (SID). Eligible patients are treated with the SEAL™ Device (Galaxy Therapeutics Inc.) and followed at 24 hours, 3, 6, and 12 months, then annually for 5 years. Digital subtraction angiography is required at 12 months. The primary efficacy endpoint is complete occlusion at 12 months without parent artery stenosis or retreatment, assessed by an independent core lab. Primary safety endpoints include neurological death through 12 months, stroke within 30 days, and ipsilateral stroke from 30 days to 1 year.

Results

As of submission, 163 WNBA, 42 WNSW, 18 ruptured for a total of 223 patients (75% female; mean age 62.4±11.3 years) have been enrolled at 45 sites; 73.4% bifurcation, 18% sidewall, and 7.6% ruptured aneurysms. Mean aneurysm width was 5.1±2.1mm, neck size of 3.6±1.3mm and neck-to-dome ratio of 1.4±0.3mm. SEAL Arc was used in 62.5% and SEAL Base in 37.5%. Technical success rate is 100% for WNBA, 97.1% WNSW, 100% ruptured. No peri-procedural permanent strokes or new subarachnoid hemorrhages were reported after 3 months. The interim complete occlusion rate for the available data was 22/23 (95.7%) and 3/3 (100%); at 3 and 6 months, respectively.

Conclusion

The preliminary safety and efficacy of the SEAL™ intrasaccular device is promising; final updates will be presented at the SNIS late-breaking session.

Registration

ClinicalTrials.gov Identifier: NCT05831202

Disclosures

B. Jankowitz: None. D. Altschul: None. S. Boo: None. D. Tonetti: None. S. Hussain: None. D. Lopes: None. S. Xin: None. R. Hanel: None. S. Dandapat: None. D. Fiorella: None. E. Afreen: None. R. Grandhi: None. W. Ares: None. T. Kass-Hout: None. V. Bansal: None. H. Cuellar-Saenz: None. N. Swamy: None. V. Srinivasan: None. A. Khaldi: None. S. Wolfe: None. S. Majidi: None. G. Dabus: None. M. Ezzeldin: None. P. Khandelwal: None. P. Bhuva: None. L. Elijovich: None. R. Starke: None. A. Coon: None. S. Janjua: None. J. Delgado: None. J. Davies: None. J. Eliyas: None. K. Ebersole: None. R. Kellogg: None. R. Priest: None. I. Abecassis: None. F. Almufti: None. B. Pabón: None. E. Pereira: None. A. Badruddin: None. K. Woodward: None. T. Wolfe: None. P. Jabbour: None. S. Roychowdhury: None. M. Oliver: None. C. Langerford: None. O. Zaidat: None.