Catheterization, Peripheral Clinical Trial
Official title:
A Feasibility, Multi Center Multinational Randomized Open Label Study, to Evaluate the Safety and Performance of the CiTop™ Guidewire for Crossing Total Occlusion in Peripheral Arteries.
The main objectives of the study are:
To evaluate the performance and safety of the CiTop guidewire, while attempting to cross
thru total occlusions of various dimensions and morphology.
To compare the safety and efficacy of the CiTop guidewire with standard guidewires in terms
of impact on the treated artery. Following operation of the CiTop device, angiography
demonstrated successful crossing of the occlusion with no visible evidence of arterial wall
injury, dissection, or distal embolization.
To assess ease of operation and the level of integration of the CiTop with standard
interventional angiography procedure: Balloon angioplasty, placement of stent.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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