Skip to main content
OpenTrials
Completed

NCT Number: NCT01120379

XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA Long Term Follow-up Cohort)

XIENCE V USA is a prospective, multi-center, multi-cohort post-approval study. The objectives of this study are

* To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in real world settings, and * To support the Food and Drug Administration (FDA) dual antiplatelet therapy (DAPT) initiative. This initiative is designed to evaluate the composite of all death, myocardial infarction (MI) and stroke (MACCE) and the survival of patients that are free from Academic Research Consortium (ARC) definite or probable stent thrombosis (ST) and that have been treated with drug eluting stents (DES) and extended dual antiplatelet therapy.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Coronary Occlusion Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Artery Stenosis Coronary Disease Coronary Restenosis Coronary Stenosis Heart Diseases Myocardial Ischemia Vascular Disease Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Abbott Vascular

Santa Clara, California, 95054, United States

About this study

Among patients enrolled in the XIENCE V USA who have completed Study Phase I, some will be eligible to participate in the XIENCE V USA Long Term Follow-up (LTF) Cohort. This LTF cohort is a prospective, open-label, multi-center, observational, single-arm study is designed to evaluate XIENCE V EECSS continued safety and effectiveness in real world settings from 1 year after the index procedure up to 5 years. The XIENCE V USA LTF cohort will consist of the following from the initial 5,000 patients:

  • The first 1,500 on-label patients who are treated in accordance with the XIENCE V EECSS Instruction for Use (IFU), and consecutively enrolled in the XIENCE V USA study
  • The remaining patients who do not participate in the HCRI-DAPT cohort
  • Data monitoring committee up to two years

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient agrees to participate in this study by signing the Institutional Review Board approved informed consent form.

Exclusion criteria

  • The inability to obtain an informed consent.
  • Age limit is determined by investigator.
  • There are no angiographic inclusion or exclusion criteria for this study.

Treatment and study plan

XIENCE V® EECSS

Device

Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.

Primary outcomes

  1. Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Consortium)

    Time frame: 2 years

    Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).

  2. Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Consortium)

    Time frame: 3 years

    Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).

  3. Stent Thrombosis (Definite and Probable) as Defined by ARC

    Time frame: 4 years

    Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).

  4. Composite Rate of Cardiac Death and Any Myocardial Infarction [MI] (ARC Defined).

    Time frame: 2 years

  5. Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined).

    Time frame: 3 years

  6. Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined).

    Time frame: 4 years

Secondary outcomes

  1. Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)

    Time frame: 2 years

  2. Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)

    Time frame: 3 years

  3. Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)

    Time frame: 4 years

  4. Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG]

    Time frame: 2 years

  5. Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG]

    Time frame: 3 years

  6. Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG]

    Time frame: 4 years

  7. Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)

    Time frame: 2 years

  8. Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)

    Time frame: 3 years

  9. Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)

    Time frame: 4 years

  10. Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)

    Time frame: 2 years

  11. Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)

    Time frame: 3 years

  12. Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)

    Time frame: 4 years

  13. Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)

    Time frame: 2 years

  14. Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)

    Time frame: 3 years

  15. Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)

    Time frame: 4 years

  16. Any MI (Q-wave and Non Q-wave)

    Time frame: 2 years

  17. Any MI (Q-wave and Non Q-wave)

    Time frame: 3 years

  18. Any MI (Q-wave and Non Q-wave)

    Time frame: 4 years

  19. Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)

    Time frame: 2 years

  20. Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)

    Time frame: 3 years

  21. Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)

    Time frame: 4 years

  22. Major Bleeding Complications

    Time frame: 2 years

    Major bleeding complications consisted of Clinical Events Committee (CEC)-adjudicated Thrombolysis In Myocardial Infarction (TIMI) major bleeding through 2-year follow-up and site reported major bleeding after 2 years.

  23. Major Bleeding Complications (Site Reported)

    Time frame: 3 years

    Major bleeding complications consisted of CEC-adjudicated TIMI major bleeding through 2-year follow-up and site reported major bleeding after 2 years.

  24. Major Bleeding Complications

    Time frame: 4 years

    Major bleeding complications consisted of CEC-adjudicated TIMI major bleeding through 2-year follow-up and site reported major bleeding after 2 years.

  25. Dual Antiplatelet Medication Usage

    Time frame: 2 years

    Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 2-year visit is 688-772 days.

  26. Dual Antiplatelet Medication Usage

    Time frame: 3 years

    Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 3-year visit is 1053-1137 days.

  27. Dual Antiplatelet Medication Usage

    Time frame: 4 years

    Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 4-year visit is 1502 days.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) USA Post-Approval Study (XIENCE V® USA Long Term Follow-up Cohort)

Acronym: XVU-LTF

Important dates

Study start
2008
Primary completion
2011
Study completion
2013
First posted
May 10, 2010
Registry last updated
Jun 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.