Safety & Performance Randomized Study of the CiTop™ Guidewire for Peripheral CTO
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00482742|
Recruitment Status : Terminated (product development was cancelled)
First Posted : June 5, 2007
Last Update Posted : July 9, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Catheterization, Peripheral||Device: CiTop(TM) Guidewire||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
|Lifestyle counseling||Device: CiTop(TM) Guidewire|
|Metformin||Device: CiTop(TM) Guidewire|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|