Status:
COMPLETED
Guidewire for Chronic Total Occlusion
Lead Sponsor:
Tokai University
Collaborating Sponsors:
Abbott Medical Devices
Kaneka Medical America LLC
Conditions:
Coronary Occlusion
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
Under the circumstances that appropriate first-choice guidewires for percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) have yet to be established, the objective of this study ...
Detailed Description
Background. Although the success rate of PCI for CTO is yet to reach a satisfactory level, prognoses have been improved in successful cases. The greatest challenge is the passage of the guidewire and ...
Eligibility Criteria
Inclusion
- Chronic total occlusion (CTO) lesion in native coronary artery
- De novo lesion
- Elective procedure
Exclusion
- No indication of PCI
- Prior failed lesion
- Restenotic or in-stent restenotic lesion
- Vein or arterial grafts
- Younger than 20 years old
- Pregnant woman
- Patients who gave no informed consent
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00987610
Start Date
October 1 2009
End Date
December 1 2014
Last Update
May 4 2015
Active Locations (25)
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1
Toyohashi Heart Center
Toyohashi, Aichi-ken, Japan
2
The Jikei University Kashiwa Hospital
Kashiwa, Chiba, Japan
3
Tokai University
Isehara, Kanagawa, Japan, 259-1193
4
Shonan Kamakura General Hospital
Kamakura, Kanagawa, Japan