Safety and efficacy of target vessel catheterization with the new steerable microcatheter Direxion compared with a standard microcatheter: a prospective, preclinical trial.

PURPOSE: To assess the potential of a steerable microcatheter in a comparative preclinical trial.
METHODS: A total of 100 small target vessels of the lower limbs with a maximum diameter of 3 mm were prospectively randomized to catheterize with either the preshaped torqueable Direxion™ (J tip shape; Boston Scientific, Natick, MA) or a similarly steam-shaped Renegade™ microcatheter (Boston Scientific) in a porcine model. Catheterization was first performed in combination with a microguidewire and afterwards without.
RESULTS: No significant differences were found for the mean vessel diameter in the Direxion (1.53 ± 0.44 mm; n = 50) or Renegade (1.62 ± 0.43 mm; n = 50; p = 0.35) group. Guidewire-assisted catheterization was successful in all target vessels, whereas access was achieved in most cases with the guidewire alone. However, when it became necessary to steer the Direxion actively, this was regarded as key to obtain vessel access in three of four target vessels (75 %). Vessel catheterization without guidewire was significantly more successful with the Direxion (88 %; n = 44) compared with the Renegade (32 %; n = 16; p < 0.0001). In addition, this catheterization technique was also significantly faster with the Direxion compared with guidewire-assisted vessel catheterization with the Renegade (16.1 ± 14.4 sec compared with 27.1 ± 24.7 sec; p = 0.011).
CONCLUSIONS: The Direxion microcatheter demonstrated unique steerability characteristics, which makes it a promising new tool especially for complex coaxial endovascular procedures.

RCT Entities:   Population Interventions Outcomes