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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00631228 |
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Date of registration:
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28/02/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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XIENCE V® Everolimus Eluting Coronary Stent System India Post-marketing Single-arm Study
XIENCE V India |
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Scientific title:
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XIENCE V® Everolimus Eluting Coronary Stent System India Post-marketing Single-Arm Study |
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Date of first enrolment:
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June 2008 |
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Target sample size:
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1000 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00631228 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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Countries of recruitment
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India
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Contacts
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Name:
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Ashok Seth, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Max Devki Devi Heart & Vascular Institute |
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Name:
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Tejas Patel, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Krishna Heart Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- The inability to obtain an informed consent is an exclusion criterion.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Coronary Disease
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Coronary Artery Disease
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Coronary Restenosis
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Intervention(s)
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Device: XIENCE V® Everolimus Eluting Coronary Stent
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Primary Outcome(s)
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Composite endpoint of cardiac death and myocardial infarction (MI)
[Time Frame: at 1 year]
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Stent thrombosis rates as defined by Academic Research Consortium (ARC)
[Time Frame: Annually through to 3 years]
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Secondary Outcome(s)
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Any MI (Q-wave and non Q-wave)
[Time Frame: at 30, 180 days and at 2 and 3 years]
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Stent thrombosis
[Time Frame: 24 hours (acute) and 30 days (sub-acute)]
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Death (cardiac death, vascular death, and non-cardiovascular death)
[Time Frame: at 30, 180 days and at 2 and 3 years]
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Composite rate of cardiac death , any MI (Q-wave and non Q-wave) attributed to the target vessel, and target lesion revascularization (PCI and CABG)
[Time Frame: at 30, 180 days and at 2 and 3 years]
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Patient health status (symptoms, physical function, and quality of life) assessed by the Seattle Angina Questionnaire
[Time Frame: at baseline, 180 days, and 1 year]
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Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy
[Time Frame: at 14, 30, 180 days and at 1, 2 and 3 years]
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Clinical device and procedural success
[Time Frame: Acute]
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Composite rate of all death and any MI (Q-wave and non Q-wave)
[Time Frame: at 30, 180 days and at 2 and 3 years]
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Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization (PCI and CABG)
[Time Frame: 30, 180 days and 1, 2 and 3 years]
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Revascularization (target lesion, target vessel [TVR], and non-target vessel) (PCI and CABG)
[Time Frame: at 30, 180 days and at 1, 2 and 3 years]
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Major bleeding complications
[Time Frame: at 14, 30, 180 days and at 1, 2 and 3 years]
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Composite rate of cardiac death and any MI (Q-wave and non Q-wave)
[Time Frame: at 30, 180 days and at 2 and 3 years]
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Secondary ID(s)
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07-378
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REFCTRI000213, 21-10-2008
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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