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

XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) 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.

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Coronary Artery Disease; Coronary Disease; Coronary Restenosis; Chronic Coronary Occlusion; Vascular Disease; Coronary Artery Stenosis
• Intervention / Treatment: Device: XIENCE V® EECSS

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

• Study Type: Observational
• Enrollment (Actual): 5034

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Clara, California, United States, 95054
      • Abbott Vascular

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Consortium)	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 years
Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Consortium)	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 years
Stent Thrombosis (Definite and Probable) as Defined by ARC	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 years
Composite Rate of Cardiac Death and Any Myocardial Infarction [MI] (ARC Defined).		2 years
Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined).		3 years
Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined).		4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)		2 years
Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)		3 years
Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)		4 years
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]		2 years
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]		3 years
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]		4 years
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)		2 years
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)		3 years
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)		4 years
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)		2 years
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)		3 years
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)		4 years
Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)		2 years
Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)		3 years
Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)		4 years
Any MI (Q-wave and Non Q-wave)		2 years
Any MI (Q-wave and Non Q-wave)		3 years
Any MI (Q-wave and Non Q-wave)		4 years
Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)		2 years
Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)		3 years
Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)		4 years
Major Bleeding Complications	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.	2 years
Major Bleeding Complications (Site Reported)	Major bleeding complications consisted of CEC-adjudicated TIMI major bleeding through 2-year follow-up and site reported major bleeding after 2 years.	3 years
Major Bleeding Complications	Major bleeding complications consisted of CEC-adjudicated TIMI major bleeding through 2-year follow-up and site reported major bleeding after 2 years.	4 years
Dual Antiplatelet Medication Usage	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.	2 years
Dual Antiplatelet Medication Usage	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.	3 years
Dual Antiplatelet Medication Usage	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.	4 years

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Publications and helpful links

Helpful Links

• NCT00676520
• NCT01106534

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: May 6, 2010
• First Submitted That Met QC Criteria: May 7, 2010
• First Posted (Estimate): May 10, 2010

Study Record Updates

• Last Update Posted (Estimate): June 22, 2015
• Last Update Submitted That Met QC Criteria: May 26, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Stents; Angioplasty; drug eluting stents; Stent thrombosis
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Vascular Diseases; Ischemia; Coronary Occlusion; Coronary Stenosis; Coronary Restenosis
• Other Study ID Numbers: 06-374B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No