| February 28, 2008 |
| June 17, 2009 |
| June 2008 |
| June 2010 (final data collection date for primary outcome measure) |
- Stent thrombosis rates as defined by Academic Research Consortium (ARC) [ Time Frame: Annually through to 5 years ] [ Designated as safety issue: Yes ]
- Composite endpoint of cardiac death and myocardial infarction (MI) [ Time Frame: at 1 year ] [ Designated as safety issue: Yes ]
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- Stent thrombosis rates as defined by Academic Research Consortium (ARC) [ Time Frame: through to 5 years ] [ Designated as safety issue: Yes ]
- Composite endpoint of cardiac death and myocardial infarction (MI) [ Time Frame: at 1 year ] [ Designated as safety issue: Yes ]
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| Complete list of historical versions of study NCT00631228 on ClinicalTrials.gov Archive Site |
- Composite rate of cardiac death and any MI (Q-wave and non Q-wave) [ Time Frame: at 30, 180 days and at 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
- Composite rate of all death and any MI (Q-wave and non Q-wave) [ Time Frame: at 30, 180 days and at 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
- 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 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
- Death (cardiac death, vascular death, and non-cardiovascular death) [ Time Frame: at 30, 180 days and at 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
- Any MI (Q-wave and non Q-wave) [ Time Frame: at 30, 180 days and at 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
- Major bleeding complications [ Time Frame: at 14, 30, 180 days and at 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
- Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy [ Time Frame: at 14, 30, 180 days and at 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
- Revascularization (target lesion, target vessel [TVR], and non-target vessel) (PCI and CABG) [ Time Frame: at 30, 180 days and at 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
- Clinical device and procedural success [ Time Frame: Acute ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- Stent thrombosis [ Time Frame: 24 hours (acute) and 30 days (sub-acute) ] [ Designated as safety issue: Yes ]
- 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, 3, 4, and 5 years ] [ Designated as safety issue: Yes ]
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- Composite rate of cardiac death and MI (Q-wave and non Q-wave) [ Time Frame: at 30, 180 days and at 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
- Composite rate of death and MI (Q-wave and non Q-wave) [ Time Frame: at 30, 180 days and at 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
- Composite rate of cardiac death, MI (Q-wave and non Q-wave), and target lesion revascularization (TLR) ([PCI] and [CABG]) [ Time Frame: at 30, 180 days and at 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
- Death (cardiac death, vascular death, and non-cardiovascular death) [ Time Frame: at 30, 180 days and at 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
- MI (Q-wave and non Q-wave) [ Time Frame: at 30, 180 days and at 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
- Major bleeding complications [ Time Frame: at 14, 30, 180 days and at 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
- Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy [ Time Frame: at 14, 30, 180 days and at 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
- Revascularization (target lesion, target vessel [TVR], and non-target vessel) (PCI and CABG) [ Time Frame: at 30, 180 days and at 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
- Clinical device and procedural success [ Time Frame: Acute ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
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| |
| XIENCE V® Everolimus Eluting Coronary Stent System India Post-Marketing Registry |
| XIENCE V® Everolimus Eluting Coronary Stent System India Post-Marketing Registry |
XIENCE V® India is a prospective, open-label, multi-center, observational, single-arm registry to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings. |
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 controlled pre-market trials. This study will evaluate XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) performance in the "real world" when used by a broad group of physicians at a variety of health care facilities. Consequently, this protocol will include all consecutively enrolled patients in India who consent to participate and receive the XIENCE V® EECSS, which is expected to represent the range of clinical use during commercialization.
Adjunctive anti-platelet therapy is a critical factor in optimizing long term DES safety. Despite established guidelines that recommend 6-12 months dual antiplatelet therapy, patients with DES implants frequently stop taking their medication early. Consequently, XIENCE V® EECSS India Post-marketing Registry (XIENCE V® India) follow-up will document patient adherence and persistence with adjunctive antiplatelet drug therapy at several time points throughout the study. |
| Phase IV |
| Observational |
| Cohort, Prospective |
- Coronary Disease
- Coronary Artery Disease
- Coronary Restenosis
|
| Device: XIENCE V® Everolimus Eluting Coronary Stent |
| The group will be monitored to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings. |
| |
| |
| Active, not recruiting |
| 1000 |
| June 2013 |
| June 2010 (final data collection date for primary outcome measure) |
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.
|
| Both |
|
| No |
| Contact information is only displayed when the study is recruiting subjects |
| India |
| |
| NCT00631228 |
| Vivian Mao, Abbott Vascular |
| 07-378 |
| Abbott Vascular |
|
| Principal Investigator: |
Ashok Seth, MD |
Max Devki Devi Heart & Vascular Institute |
|
| Principal Investigator: |
Tejas Patel, MD |
Krishna Heart Institute |
|
|
| Abbott Vascular |
| June 2009 |