Efficacy and safety of a new torque-controlled angiographic catheter in cerebral angiography: A multicenter, randomized, open-label trial
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
Affiliations
Seung Min Shin
Department of Neurosurgery, Soonchunhyang University Cheonan Hospital, College of Medicine, Soonchunhyang University, Cheonan, Republic of Korea
Ji Young Lee
Department of Neurosurgery, Soonchunhyang University Cheonan Hospital, College of Medicine, Soonchunhyang University, Cheonan, Republic of Korea
Heo Nam Hun
Clinical Trial Center, Soonchunhyang University Cheonan Hospital, Cheonan, Republic of Korea
Se Woong Choo
Division of STENT, GENOSS, Suwon, Republic of Korea
Yong Pyo Jeon
Division of STENT, GENOSS, Suwon, Republic of Korea
Jaewoo Chung
Department of Neurosurgery, Dankook University Hospital, College of Medicine, Dankook University, Cheonan, Republic of Korea
Jung Ho Ko
Department of Neurosurgery, Dankook University Hospital, College of Medicine, Dankook University, Cheonan, Republic of Korea
Hae-Won Koo
Department of Neurosurgery, Ilsan Paik Hospital, College of Medicine, Inje University, Goyang, Republic of Korea
Dong Seoung Shin
Department of Neurosurgery, Soonchunhyang University Bucheon Hospital, College of Medicine, Soonchunhyang University, Bucheon, Republic of Korea
Man Ryul Lee
Soonchunhyang, Institute of Medi-Bio Science (SIMS), Soonchunhyang University, Cheonan, Republic of Korea
Jae Sang Oh
Department of Neurosurgery, Soonchunhyang University Cheonan Hospital, College of Medicine, Soonchunhyang University, Cheonan, Republic of Korea; Department of Neurosurgery, Uijeonbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Uijeonbu, Republic of Korea; Corresponding author. Department of Neurosurgery Uijeonbu St. Mary's Hospital College of Medicine The Catholic University of Korea, 271 Cheonbo-ro, Uijeonbu 11765, 31151, Republic of Korea.
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 < 0.001). No marked adverse cerebrovascular accidents or vessel damage occurred in either group during the procedure. The differences between the two groups in terms of the device rotational force and operator satisfaction were 1.836 (1.765–1.907) and 2.092 (2.000–2.183), respectively. The new torque-controlled catheter showed superior device rotational force satisfaction, operator satisfaction, and manufacturer satisfaction, with statistical significance. Conclusion: The new torque-controlled catheter was effective, safe, and convenient compared to the control group catheters for diagnostic cerebrovascular angiography.
