NCT00482742

Safety & Performance Randomized Study of the CiTop™ Guidewire for Peripheral CTO

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.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Ovalum · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Catheterization, Peripheral

Interventions

Type	Name	Description
DEVICE	CiTop(TM) Guidewire

Timeline

• Start date: 2006-10-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2007-06-05
• Last updated: 2013-07-09

Locations

3 sites across 2 countries: Croatia, Israel