Status:
COMPLETED
SPIRIT V: Post-marketing Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in Europe
Lead Sponsor:
Abbott Medical Devices
Conditions:
Coronary Disease
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients ...
Detailed Description
The SPIRIT V Clinical Evaluation consists of two concurrent studies,the Diabetic Sub-Study and the Registry. The SPIRIT V Registry is a prospective, single arm, multi-center registry evaluating perfo...
Eligibility Criteria
Inclusion
- at least 18 years
- able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the XIENCE V® EECSS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site
- evidence of myocardial ischemia
- acceptable candidate for coronary artery bypass graft (CABG) surgery
- undergo all CIP-required follow-up examinations
- artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned XIENCE V® EESCC
- target lesions must be de novo lesions
- target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate
- target lesion ≤ 28 mm in length by visual estimate
Exclusion
- Patient is already participating in another device or drug study or has completed the follow-up phase of another study within the last 30 days.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
2700 Patients enrolled
Trial Details
Trial ID
NCT00402272
Start Date
November 1 2006
End Date
June 1 2010
Last Update
October 14 2010
Active Locations (93)
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1
Salzburger Landeskliniken
Salzburg, Austria
2
UCL St Luc
Brussels, Belgium
3
ULB Erasmus Hospital
Brussels, Belgium
4
UZ Gent
Ghent, Belgium