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Completed

NCT Number: NCT00676520

XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA-Phase 1)

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Abbott Vascular

Santa Clara, California, 95054, United States

About this study

Study Phase I is from index procedure to 1 year. This prospective, open-label, multi-center, observational, single-arm study is designed to evaluate XIENCE V EECSS safety and effectiveness in real world settings up to 1 year after implantation. The primary endpoint is the stent thrombosis (definite and probable) rate up to 1 year as ARC. The co-primary endpoint is the composite rate of cardiac death and any MI at 1 year. Up to 8,000 patients are planned to be consecutively enrolled at up to 275 sites in the U.S. Clinical follow-up will occur at 14, 30, 180 days and 1 year.

All patients enrolled in the XIENCE V USA who have completed Study Phase I will be evaluated at 1 year to determine whether they are eligible to participate in one of the following cohorts in Study Phase II: XIENCE V USA Long Term Follow-up (LTF) Cohort, Harvard Clinical Research Institute (HCRI) DAPT Cohort, or Abbott Vascular (AV) DAPT Cohort.

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® Everolimus Eluting Coronary Stent

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 Constortium).

    Time frame: up to 1 year

    ARC Defines Stent Thrombosis in the following way:

    Definite Stent Thrombosis: Angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region AND at least ONE of the following, additional criteria:

    Acute ischemic symptoms Ischemic ECG changes Elevated cardiac biomarkers

    Probable Stent Thrombosis: Any unexplained death within 30 days of stent implantation or any myocardial infarction, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause

    Possible Stent Thrombosis Any unexplained death beyond 30 days

    For further information on ARC definitions, please refer to the following website: http://circ.ahajournals.org/content/115/17/2344.full#sec-1

  2. Composite Rate of Cardiac Death and Any Myocardial Infarction (MI)

    Time frame: 1 year

    MI= ARC (Academic Research Constortium) defined

Secondary outcomes

  1. Clinical Device Success

    Time frame: acute: post index procedure until hospital discharge

  2. Procedural Success

    Time frame: acute: post index procedure until hospital discharge

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

    Time frame: at 30 days

    MI= Academic Research Consortium (ARC) defined

  4. Composite Rate of Cardiac Death and Any MI (Q-wave and Non Q-wave)

    Time frame: at 180 days

    MI= Academic Research Consortium (ARC) defined

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

    Time frame: at 30 days

    MI= Academic Research Consortium (ARC) defined

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

    Time frame: at 180 days

    MI= Academic Research Consortium (ARC) defined

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

    Time frame: at 1 year

    MI= Academic Research Consortium (ARC) defined

  8. 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: at 30 days

    MI= Academic Research Consortium (ARC) defined

  9. 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: at 180 days

    MI= Academic Research Consortium (ARC) defined

  10. 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: at 1 year

    MI= Academic Research Consortium (ARC) defined

  11. 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: at 30 days

    MI= Academic Research Consortium (ARC) defined

  12. 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: at 180 days

    MI= Academic Research Consortium (ARC) defined

  13. 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: at 1 year

    MI= Academic Research Consortium (ARC) defined

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

    Time frame: at 30 days

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

    Time frame: at 180 days

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

    Time frame: at 1 year

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

    Time frame: at 30 days

    MI= Academic Research Consortium (ARC) defined

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

    Time frame: at 180 days

    MI= Academic Research Consortium (ARC) defined

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

    Time frame: at 1 year

    MI= Academic Research Consortium (ARC) defined

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

    Time frame: at 30 days

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

    Time frame: at 180 days

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

    Time frame: at 1 year

  23. Major Bleeding Complications

    Time frame: at 14 days

    by TIMI flow

  24. Major Bleeding Complications

    Time frame: at 30 days

    by TIMI flow

  25. Major Bleeding Complications

    Time frame: at 180 days

    by TIMI flow

  26. Major Bleeding Complications

    Time frame: at 1 year

    by TIMI flow

  27. Dual Antiplatelet Medication Usage

    Time frame: at 14 days

    Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days.

    Adjunctive antiplatelet therapy includes: Aspirin & Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel).

    Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications.

  28. Dual Antiplatelet Medication Usage

    Time frame: at 30 days

    Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days.

    Adjunctive antiplatelet therapy includes: Aspirin & Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel).

    Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications.

  29. Dual Antiplatelet Medication Usage

    Time frame: at 180 days

    Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days.

    Adjunctive antiplatelet therapy includes: Aspirin & Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel).

    Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications.

  30. Dual Antiplatelet Medication Usage

    Time frame: at 1 year

    Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days.

    Adjunctive antiplatelet therapy includes: Aspirin & Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel).

    Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications.

  31. Dual Antiplatelet Therapy Non-compliance Through 1 Year

    Time frame: 1 year

    Defined as patients who had at least 1 day without using either aspirin or thienopyridine from 1 to 407 days post index procedure.

  32. 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: at 30 days

    MI= Academic Research Consortium (ARC) defined

  33. 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: at 180 days

    MI= Academic Research Consortium (ARC) defined

  34. 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: at 1 year

    MI= Academic Research Consortium (ARC) defined

  35. Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire)

    Time frame: at baseline

    SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:

    Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do.

    Treatment Satisfaction: how well a patient understands her care and what she thinks of it.

    Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind.

    Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100.

  36. Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire)

    Time frame: at 180 days

    SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:

    Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do.

    Treatment Satisfaction: how well a patient understands her care and what she thinks of it.

    Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind.

    Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100.

  37. Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire)

    Time frame: at 1 year

    SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:

    Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do.

    Treatment Satisfaction: how well a patient understands her care and what she thinks of it.

    Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind.

    Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100.

  38. SAQ (Seattle Angina Questionaire)

    Time frame: at baseline

    SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:

    Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do.

    Treatment Satisfaction: how well a patient understands her care and what she thinks of it.

    Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind.

    Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100.

  39. SAQ (Seattle Angina Questionaire)

    Time frame: 180 days

    SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:

    Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do.

    Treatment Satisfaction: how well a patient understands her care and what she thinks of it.

    Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind.

    Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100.

  40. SAQ (Seattle Angina Questionaire)

    Time frame: 1 year

    SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:

    Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do.

    Treatment Satisfaction: how well a patient understands her care and what she thinks of it.

    Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind.

    Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100.

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

Acronym: XVU-Phase 1

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
May 13, 2008
Registry last updated
Nov 20, 2012

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.

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