Status:
COMPLETED
XIENCE V® Everolimus Eluting Coronary Stent System India Post-marketing Single-arm Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Coronary Disease
Coronary Artery Disease
Eligibility:
All Genders
Brief Summary
XIENCE V® India is a prospective, open-label, multi-center, observational, single-arm study to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Detailed Description
Long term surveillance studies using a drug eluting stent (DES) may help elucidate mechanisms responsible for death, myocardial infarction, and late stent thrombosis risks not observed during controll...
Eligibility Criteria
Inclusion
- The patient agrees to participate in this study by signing the EC approved informed consent form. Alternatively, the patient's legally authorized representative agrees to the patient's participation in this study and signs the informed consent form.
Exclusion
- The inability to obtain an informed consent is an exclusion criterion.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00631228
Start Date
June 1 2008
End Date
August 1 2012
Last Update
August 14 2012
Active Locations (18)
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1
CARE Hospital
Hyderabaad, Andhra Pradesh, India, 500034
2
Krishna Heart Institute,
Hyderabad, Andhra Pradesh, India, 5000003
3
Krishna Heart Institute
Ahmedabad, Gujarat, India, 380 006
4
Jehangir Hospital
Pune, Pune, India, 411001