Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482742
Status:
TERMINATED
Last Update Posted:
2013-07-09
First Post:
2007-06-03
Brief Title:
Safety Performance Randomized Study of the CiTop Guidewire for Peripheral CTO
Sponsor:
Ovalum
Organization:
Ovalum
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
product development was cancelled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None