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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00676520
First received: October 16, 2007
Last updated: October 10, 2012
Last verified: October 2012
  Purpose

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.

Condition Intervention Phase
Coronary Artery Disease
Device: XIENCE V® Everolimus Eluting Coronary Stent
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) USA Post-Approval Study

Resource links provided by NLM:


Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Constortium). [ Time Frame: up to 1 year ] [ Designated as safety issue: Yes ]

    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


  • Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    MI= ARC (Academic Research Constortium) defined


Secondary Outcome Measures:
  • Clinical Device Success [ Time Frame: acute: post index procedure until hospital discharge ] [ Designated as safety issue: No ]
  • Procedural Success [ Time Frame: acute: post index procedure until hospital discharge ] [ Designated as safety issue: No ]
  • Composite Rate of Cardiac Death and Any MI (Q-wave and Non Q-wave) [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]
    MI= Academic Research Consortium (ARC) defined

  • Composite Rate of Cardiac Death and Any MI (Q-wave and Non Q-wave) [ Time Frame: at 180 days ] [ Designated as safety issue: Yes ]
    MI= Academic Research Consortium (ARC) defined

  • Composite Rate of All Death and Any MI (Q-wave and Non Q-wave) [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]
    MI= Academic Research Consortium (ARC) defined

  • Composite Rate of All Death and Any MI (Q-wave and Non Q-wave) [ Time Frame: at 180 days ] [ Designated as safety issue: Yes ]
    MI= Academic Research Consortium (ARC) defined

  • Composite Rate of All Death and Any MI (Q-wave and Non Q-wave) [ Time Frame: at 1 year ] [ Designated as safety issue: Yes ]
    MI= Academic Research Consortium (ARC) defined

  • 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 ] [ Designated as safety issue: Yes ]
    MI= Academic Research Consortium (ARC) defined

  • 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 ] [ Designated as safety issue: Yes ]
    MI= Academic Research Consortium (ARC) defined

  • 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 ] [ Designated as safety issue: Yes ]
    MI= Academic Research Consortium (ARC) defined

  • 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 ] [ Designated as safety issue: Yes ]
    MI= Academic Research Consortium (ARC) defined

  • 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 ] [ Designated as safety issue: Yes ]
    MI= Academic Research Consortium (ARC) defined

  • 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 ] [ Designated as safety issue: Yes ]
    MI= Academic Research Consortium (ARC) defined

  • Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death) [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]
  • Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death) [ Time Frame: at 180 days ] [ Designated as safety issue: Yes ]
  • Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death) [ Time Frame: at 1 year ] [ Designated as safety issue: Yes ]
  • Any MI (Q-wave and Non Q-wave) [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]
    MI= Academic Research Consortium (ARC) defined

  • Any MI (Q-wave and Non Q-wave) [ Time Frame: at 180 days ] [ Designated as safety issue: Yes ]
    MI= Academic Research Consortium (ARC) defined

  • Any MI (Q-wave and Non Q-wave) [ Time Frame: at 1 year ] [ Designated as safety issue: Yes ]
    MI= Academic Research Consortium (ARC) defined

  • Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG) [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]
  • Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG) [ Time Frame: at 180 days ] [ Designated as safety issue: Yes ]
  • Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG) [ Time Frame: at 1 year ] [ Designated as safety issue: Yes ]
  • Major Bleeding Complications [ Time Frame: at 14 days ] [ Designated as safety issue: Yes ]
    by TIMI flow

  • Major Bleeding Complications [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]
    by TIMI flow

  • Major Bleeding Complications [ Time Frame: at 180 days ] [ Designated as safety issue: Yes ]
    by TIMI flow

  • Major Bleeding Complications [ Time Frame: at 1 year ] [ Designated as safety issue: Yes ]
    by TIMI flow

  • Dual Antiplatelet Medication Usage [ Time Frame: at 14 days ] [ Designated as safety issue: No ]

    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.


  • Dual Antiplatelet Medication Usage [ Time Frame: at 30 days ] [ Designated as safety issue: No ]

    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.


  • Dual Antiplatelet Medication Usage [ Time Frame: at 180 days ] [ Designated as safety issue: No ]

    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.


  • Dual Antiplatelet Medication Usage [ Time Frame: at 1 year ] [ Designated as safety issue: No ]

    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.


  • Dual Antiplatelet Therapy Non-compliance Through 1 Year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Defined as patients who had at least 1 day without using either aspirin or thienopyridine from 1 to 407 days post index procedure.

  • 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 ] [ Designated as safety issue: Yes ]
    MI= Academic Research Consortium (ARC) defined

  • 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 ] [ Designated as safety issue: Yes ]
    MI= Academic Research Consortium (ARC) defined

  • 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 ] [ Designated as safety issue: Yes ]
    MI= Academic Research Consortium (ARC) defined

  • Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire) [ Time Frame: at baseline ] [ Designated as safety issue: No ]

    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.


  • Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire) [ Time Frame: at 180 days ] [ Designated as safety issue: No ]

    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.


  • Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire) [ Time Frame: at 1 year ] [ Designated as safety issue: No ]

    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.


  • SAQ (Seattle Angina Questionaire) [ Time Frame: at baseline ] [ Designated as safety issue: No ]

    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.


  • SAQ (Seattle Angina Questionaire) [ Time Frame: 180 days ] [ Designated as safety issue: No ]

    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.


  • SAQ (Seattle Angina Questionaire) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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.



Enrollment: 8053
Study Start Date: July 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Single-arm study
Device: XIENCE V® Everolimus Eluting Coronary Stent
Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who agree to participate by signing the Institutional Review Board (IRB) approved informed consent form, and who recieve only XIENCE V® EECSS during the index procedure.

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676520

Locations
United States, California
Abbott Vascular
Santa Clara, California, United States, 95054
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: James Hermiller, MD Heart Center of Indianapolis
Principal Investigator: Mitch Krucoff, MD Duke University
  More Information

No publications provided by Abbott Vascular

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT00676520     History of Changes
Other Study ID Numbers: 06-374
Study First Received: October 16, 2007
Results First Received: June 7, 2012
Last Updated: October 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott Vascular:
Angioplasty
Coronary Restenosis
Coronary Artery Disease
Coronary Artery Restenosis
Coronary Artery Stenosis
Total Artery Occlusion
Stents
Stent Thrombosis
Total Coronary Occlusion
Vascular Disease
Myocardial Ischemia

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 24, 2014