Status:
COMPLETED
SPIRIT III Clinical Trial of the XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
Lead Sponsor:
Abbott Medical Devices
Conditions:
Stents
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is divided into 5 arms: 1. Randomized Clinical Trial (RCT): Prospective, randomized, active-controlled, single blind, parallel two-arm multi-center clinical trial in the United States (US)...
Detailed Description
The purpose of the SPIRIT III clinical trial is to evaluate the safety and efficacy of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS). The XIENCE V® EECS (XIENCE V® arm) will...
Eligibility Criteria
Inclusion
- Target lesion(s) must be located in a native epicardial vessel with visually estimated diameter between \>= 2.25 mm and \<= 4.25 mm and a lesion length \<= 32 mm
- The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of \>= 50% and \< 100% with a thrombolysis in myocardial infarction (TIMI) flow of \>= 1
- Non-study, percutaneous intervention for lesions in a non-target vessel is allowed if done \>= 90 days prior to the index procedure (subjects who received brachytherapy will be excluded from the trial)
Exclusion
- Located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and \> 20% stenosed lesion by visual estimation) arterial or saphenous vein graft
- Lesion involving a bifurcation \>= 2 mm in diameter or ostial lesion \> 50% stenosed by visual estimation or side branch requiring predilatation
- Located in a major epicardial vessel that has been previously treated with brachytherapy
- Located in a major epicardial vessel that has been previously treated with percutaneous intervention \< 9 months prior to index procedure
- Total occlusion (TIMI flow 0), prior to wire passing
- The target vessel contains thrombus
- Another significant lesion (\> 40% diameter stenosis \[DS\]) is located in the same epicardial vessel as the target lesion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
1002 Patients enrolled
Trial Details
Trial ID
NCT00180479
Start Date
June 1 2005
End Date
November 1 2011
Last Update
November 23 2011
Active Locations (65)
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1
Baptist Medical Center Princeton
Birmingham, Alabama, United States, 35211
2
Baptist Health System - Montclair
Birmingham, Alabama, United States, 35213
3
Arizona Heart Hospital
Phoenix, Arizona, United States, 85016
4
Scripps Memorial Hospital
La Jolla, California, United States, 92037