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

ABSTRACT

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.