P117 Enhancing neurothrombectomy procedures with iVascular devices (iNedit, iNdeep, and iNtercept): first results from the SEMTIC study

<h3>Introduction</h3> The iVascular neurothrombectomy devices, which include a balloon distal access catheter (iNedit), a microcatheter (iNdeep), and a stent retriever (iNtercept), have been strategically designed to incorporate the benefits of temporary proximal blood flow restriction via a balloon situated 5 cm from the catheter tip. This setup, paired with a guiding distal access catheter, facilitates clot removal through the combined action of a stent retriever and distal aspiration. <h3>Aim of Study</h3> To assess the efficacy and safety of three devices (iNedit, iNdeep, and iNtercept) in mechanical thrombectomy for patients with acute ischemic stroke due to large vessel occlusion, presented within 24 hours from symptoms onset. <h3>Methods</h3> SEMTIC is a prospective, single-arm, multi-center study with blinded outcomes assessment. Efficacy endpoints: successful reperfusion (eTICI≥2b) within three passes and mRS 0-2 at 90 days. Safety endpoints: all-cause mortality at 90 days, symptomatic intracranial hemorrhage, and embolization in a new territory. <h3>Results</h3> A total of 115 patients participated (mean age: 73.7 ± 10.5 years; 53.9% female). Successful reperfusion was 80% (95% CI: 72% to 86%) surpassing non-inferiority proportion reported in literature. Good functional outcomes (mRS 0-2): 56% (46%, 65%). All-cause 90-day mortality: 13.9% (95% CI: 8.2% to 21.6%). Symptomatic intracranial hemorrhage: 1.7% (95% CI: 0.5% to 6.1%). Embolization in a new territory: 5.2% (95% CI: 2.1% to 11.1%). <h3>Conclusion</h3> The combination of three iVascular devices proved to be highly effective in mechanical thrombectomy, demonstrating non-inferiority in successful reperfusion parameters with no safety concerns. <h3>Disclosure of Interest</h3> no.

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Published
2024-09-01
DOI
https://doi.org/10.1136/jnis-2024-esmint.153
Primary Topic
Cerebrovascular and Carotid Artery Diseases
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article
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article

P117 Enhancing neurothrombectomy procedures with iVascular devices (iNedit, iNdeep, and iNtercept): first results from the SEMTIC study

Antonio López‐Rueda, Carlos Castaño, Fernando Aparici, Carlos Domínguez Morano et al.
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Abstracts
Cerebrovascular and Carotid Artery Diseases
article

P117 Enhancing neurothrombectomy procedures with iVascular devices (iNedit, iNdeep, and iNtercept): first results from the SEMTIC study

Antonio López‐Rueda, Carlos Castaño, Fernando Aparici, Carlos Domínguez Morano, Óscar Chirife, Pedro Vega, Manuel Moreu, Alejandro Tomasello, Sara Pich, Juan Macho, Laura Domingo-Rodriguez, Carla Agustí, Fernando Delgado
article en

Abstract

<h3>Introduction</h3> The iVascular neurothrombectomy devices, which include a balloon distal access catheter (iNedit), a microcatheter (iNdeep), and a stent retriever (iNtercept), have been strategically designed to incorporate the benefits of temporary proximal blood flow restriction via a balloon situated 5 cm from the catheter tip. This setup, paired with a guiding distal access catheter, facilitates clot removal through the combined action of a stent retriever and distal aspiration. <h3>Aim of Study</h3> To assess the efficacy and safety of three devices (iNedit, iNdeep, and iNtercept) in mechanical thrombectomy for patients with acute ischemic stroke due to large vessel occlusion, presented within 24 hours from symptoms onset. <h3>Methods</h3> SEMTIC is a prospective, single-arm, multi-center study with blinded outcomes assessment. Efficacy endpoints: successful reperfusion (eTICI≥2b) within three passes and mRS 0-2 at 90 days. Safety endpoints: all-cause mortality at 90 days, symptomatic intracranial hemorrhage, and embolization in a new territory. <h3>Results</h3> A total of 115 patients participated (mean age: 73.7 ± 10.5 years; 53.9% female). Successful reperfusion was 80% (95% CI: 72% to 86%) surpassing non-inferiority proportion reported in literature. Good functional outcomes (mRS 0-2): 56% (46%, 65%). All-cause 90-day mortality: 13.9% (95% CI: 8.2% to 21.6%). Symptomatic intracranial hemorrhage: 1.7% (95% CI: 0.5% to 6.1%). Embolization in a new territory: 5.2% (95% CI: 2.1% to 11.1%). <h3>Conclusion</h3> The combination of three iVascular devices proved to be highly effective in mechanical thrombectomy, demonstrating non-inferiority in successful reperfusion parameters with no safety concerns. <h3>Disclosure of Interest</h3> no.

Abstracts
Bellvitge University Hospital (ES), Hospital Clínico San Carlos (ES), Hospital Clínic de Barcelona (ES), Hospital Universitario Reina Sofía (ES), Vall d'Hebron Hospital Universitari (ES), Barcelona IVI Clinic (ES), Hospital Universitario Central de Asturias (ES), Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol (ES), Hospital General Universitario de Alicante Doctor Balmis (ES), Instituto de Investigación Sanitaria La Fe (ES)
Openalex Percentile: Top 74%
Cerebrovascular and Carotid Artery Diseases
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