Clinical Trial: Safety and Efficacy of the CiTop™ Guidewire for Crossing Chronic Total Occlusions in Coronary Arteries
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Feasibility Study to Evaluate the Safety and Efficacy of the CiTop™ Guidewire for Crossing Chronic Total Occlusion in Coronary Arteries
Brief Summary: The CiTop™ guidewire Coronary study is a feasibility open label study, to evaluate the safety and efficacy of the CiTop™ Guidewire for crossing chronic total occlusion in Coronary arteries.
Detailed Summary:
Sponsor: Ovalum
Current Primary Outcome: Angiographic documentation of placement of CiTop™ distal to occlusion with no device related major complications. [ Time Frame: during procedure, 1day, 1week and 30 days post procedure ]
Original Primary Outcome: Angiographic documentation of placement of CiTop™ distal to occlusion with no device related major complications. [ Time Frame: During procedure, Day1, Day7 and Day30 post procedure ]
Current Secondary Outcome:
- Successful stenting [ Time Frame: During procedure, Day1, Day7 and Day30 post procedure ]
- Wire crossing duration [ Time Frame: during procedure ]
- Fluoroscopy time [ Time Frame: during procedure ]
- Amount of contrast [ Time Frame: during procedure ]
- Maneuverability of the CiTop™ up to the occlusion [ Time Frame: during procedure ]
- No mechanical damage to the device during [ Time Frame: during procedure ]
Original Secondary Outcome: • Successful stenting • Wire crossing duration • Fluoroscopy time • Amount of contrast • Lack of procedure related death, stroke, AMI • Maneuverability of the CiTop™ up to the occlusion • No mechanical damage to the device during [ Time Frame: During procedure, Day1, Day7 and Day30 post procedure ]
Information By: Ovalum
Dates:
Date Received: January 28, 2008
Date Started: August 2007
Date Completion:
Last Updated: July 17, 2008
Last Verified: July 2008
