Efficacy and safety of a new torque-controlled angiographic catheter in cerebral angiography: A multicenter, randomized, open-label trial

Autor: Seung Min Shin, Ji Young Lee, Heo Nam Hun, Se Woong Choo, Yong Pyo Jeon, Jaewoo Chung, Jung Ho Ko, Hae-Won Koo, Dong Seoung Shin, Man Ryul Lee, Jae Sang Oh
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Heliyon, Vol 10, Iss 15, Pp e35205- (2024)
Druh dokumentu: article
ISSN: 2405-8440
DOI: 10.1016/j.heliyon.2024.e35205
Popis: Objective: We aimed to examine the effectiveness and safety of a novel torque-controlled catheter for cerebral angiography. Methods: A total of 417 patients who underwent routine transfemoral cerebral angiography were enrolled in a randomized controlled study to compare the new torque-controlled and control group catheters. Device success was assessed on parameters such as the assessment of the common carotid artery, device rotation force, and success rate with the crossover group after the failed procedure. Four neurointerventionalists investigated the degree of satisfaction of using the new device. Superiority and non-inferiority tests of satisfaction scores were estimated for the new torque-controlled and the control group catheters. Results: The new torque-controlled catheter showed improved performance in terms of technical device success (92.79 vs. 98.09 %, P = 0.010), crossover after technical device failure (0 vs. 86.67 %, P = 0.004), and common carotid artery access (92.79 vs. 98.56 %, P = 0.004). The flexibility and rotational force of the new torque-controlled catheter were higher than those of the control group catheters (75.48 vs. 100 %, P
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