Safety & Performance Randomized Study of the CiTop™ Guidewire for Peripheral CTO
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00482742
|University Hospital Split|
|Split, Croatia, 21000|
|Clinical Hospital Centre Zagreb|
|Zagreb, Croatia, 10000|
|Rabin Campus, Belinson Hospital|
|Petah-Tikva, Israel, 49100|
|Principal Investigator:||Alexander Belenky, MD||Research Fund, Belinson Hospital|