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XIENCE V® Everolimus Eluting Coronary Stent System India Post-Marketing Registry (XIENCE V India)
This study is ongoing, but not recruiting participants.
Study NCT00631228   Information provided by Abbott Vascular
First Received: February 28, 2008   Last Updated: June 17, 2009   History of Changes

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 ]
  • 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 ]
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 ]
  • 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 ]
 
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.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP