A Novel Braided Stent With Customized Simulation Software for Treatment of Intracranial Aneurysms: Multicenter Prospective Trial Before Unrestricted Clinical Application.

Abstract

BACKGROUND AND OBJECTIVES:

Planning/guidance software became important tools for physicians' presurgical optimal decision-making. However, there are no intracranial stent products with specifically associated simulation software. We report the "premarket" clinical trial of a new braided stent with a customized simulation software.

METHODS:

A stent system with 3 mesh density types (16, 24, and 32 wire mesh) was designed based on computational flow dynamics technology, and a simulation software (virtual stent planner [VSP]) was developed for the optimal stent deployment planning. Stents were selected after simulation on preoperative 3D-processed angioimages, and accuracy of the VSP was evaluated.

RESULTS:

Thirty-three unruptured intracranial aneurysms were successfully treated with VSP guidance. Twenty aneurysms (61%) were anterior circulation aneurysms, and 13 (39%) were posterior circulation aneurysms. The average aneurysm size was 7.1 mm, and the mean follow-up period was 19.2 months (11-39.0). There was no major recurrence or retreatment during follow-up, 2 morbidity cases, and no mortality. VSP planning presented slightly smaller stent dimensions compared with postdeployment: 24.2 vs 25.5 mm average, error -1.3 mm, and difference rate-5.46%.

CONCLUSION:

Based on this result, the new stents and software guidance system were approved by the Ministry of Health and Welfare as a combined medical device. VSP provided precise deployment with minimal error compared with actual stent and can contribute to better stent deployment even for less experienced physicians.

• Authors: Issei Kan, Hidenori Oishi, Akio Hyodo, Shigeru Nemoto, Soichiro Fujimura, Toshihiro Ishibashi, Kazutaka Sumita, Tomoji Takigawa, Kohsuke Teranishi, Tomonobu Kodama, Naoki Kato, Hiroyuki Takao, Yuichi Murayama
• Journal: Operative neurosurgery (Hagerstown, Md.) (Oper Neurosurg (Hagerstown)) Vol. 26 Issue 2 Pg. 180-187 (Feb 01 2024) ISSN: 2332-4260 [Electronic] United States
• PMID: 37819087 (Publication Type: Clinical Trial, Journal Article, Multicenter Study)
• Copyright: Copyright © Congress of Neurological Surgeons 2023. All rights reserved.

Topics

• Humans
• Embolization, Therapeutic (methods)
• Intracranial Aneurysm (diagnostic imaging, surgery)
• Prospective Studies
• Software
• Stents