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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01120379
First received: May 6, 2010
Last updated: March 12, 2015
Last verified: March 2015
  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
Chronic Coronary Occlusion
Vascular Disease
Myocardial Ischemia
Coronary Artery Stenosis
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Device: XIENCE V® EECSS

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 (XIENCE V® USA Long Term Follow-up Cohort)

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Consortium) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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).

  • Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Consortium) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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).

  • Stent Thrombosis (Definite and Probable) as Defined by ARC [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    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).

  • Composite Rate of Cardiac Death and Any Myocardial Infarction [MI] (ARC Defined). [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined). [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined). [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Composite Rate of All Death and Any MI (Q-wave and Non Q-wave) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Composite Rate of All Death and Any MI (Q-wave and Non Q-wave) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Composite Rate of All Death and Any MI (Q-wave and Non Q-wave) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ 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 (TLR) (PCI and CABG) [ Time Frame: 2 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 (TLR) (PCI and CABG) [ Time Frame: 3 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 (TLR) (PCI and CABG) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Any MI (Q-wave and Non Q-wave) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Any MI (Q-wave and Non Q-wave) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Any MI (Q-wave and Non Q-wave) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Major Bleeding Complications [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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.

  • Major Bleeding Complications (Site Reported) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Major bleeding complications consisted of CEC-adjudicated TIMI major bleeding through 2-year follow-up and site reported major bleeding after 2 years.

  • Major Bleeding Complications [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    Major bleeding complications consisted of CEC-adjudicated TIMI major bleeding through 2-year follow-up and site reported major bleeding after 2 years.

  • Dual Antiplatelet Medication Usage [ Time Frame: 2 years ] [ 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 2-year visit is 688-772 days.

  • Dual Antiplatelet Medication Usage [ Time Frame: 3 years ] [ 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 3-year visit is 1053-1137 days.

  • Dual Antiplatelet Medication Usage [ Time Frame: 4 years ] [ 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 4-year visit is 1502 days.


Enrollment: 5034
Study Start Date: July 2008
Study Completion Date: December 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
XV-LTF cohort Device: XIENCE V® EECSS
Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.

Detailed Description:

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
  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: NCT01120379

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

Additional Information:
No publications provided

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01120379     History of Changes
Other Study ID Numbers: 06-374B
Study First Received: May 6, 2010
Results First Received: August 2, 2013
Last Updated: March 12, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott Vascular:
drug eluting stents
Stents
Angioplasty
Stent thrombosis

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Coronary Occlusion
Coronary Restenosis
Coronary Stenosis
Myocardial Ischemia
Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on April 19, 2015