Status:
COMPLETED
SPIRIT II: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System
Lead Sponsor:
Abbott Medical Devices
Conditions:
Coronary Disease
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Prospective, randomized, active-control, single blind, parallel two-arm multi-center clinical trial comparing XIENCE V® Everolimus Eluting Coronary Stent System to the approved commercially available ...
Detailed Description
The SPIRIT II trial was a randomized, single blind, active control, multi-center clinical evaluation. Subject eligibility criteria were similar to SPIRIT III and enrollment duration overlapped between...
Eligibility Criteria
Inclusion
- De novo Target lesion(s) must be located in a native epicardial vessel with diameter between 2.25 mm and 4.25 mm by visual estimate
- The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of \>= 50% and \< 100% with a 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 or if planned to be done \> 9 months after the index procedure
Exclusion
- De novo target lesion(s) located in a major epicardial vessel or a side branch that has been previously treated with any type of percutaneous intervention (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) \< 9 months prior to index procedure
- Target lesion(s) restenotic from previous intervention
- Target lesion(s) located in a major epicardial vessel that has been previously treated with brachytherapy
- Target vessel(s) contains visible thrombus
- Patient has a high probability that a procedure other than pre-dilatation, stenting and post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon or brachytherapy)
- Patient has additional clinically significant lesion(s) (\> 50% diameter stenosis) in a target vessel or side branch for which an intervention within 9 months after the index procedure may be required
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00180310
Start Date
July 1 2005
End Date
February 1 2011
Last Update
July 20 2011
Active Locations (32)
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1
Wilheminenspital der Stadt Wien
Vienna, Austria, 1160
2
A.Z. Middelheim
Antwerp, Belgium, 2020
3
C.H.R. La Citadelle
Liège, Belgium, 4000
4
C.H.U. de Liège Sart Tilman
Liège, Belgium, 4000