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

• ClinicalTrials.gov Identifier: NCT01120379
• Recruitment Status: Completed
• First Posted: May 10, 2010
• Results First Posted: October 11, 2013
• Last Update Posted: June 22, 2015
• Sponsor: Abbott Medical Devices
• Information provided by (Responsible Party): Abbott Medical Devices

Study Description

Brief Summary:

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 or disease	Intervention/treatment
Chronic Coronary Occlusion; Vascular Disease; Myocardial Ischemia; Coronary Artery Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis	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 Design

• Study Type: Observational
• Actual Enrollment: 5034 participants
• 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)
• Study Start Date: July 2008
• Actual Primary Completion Date: December 2011
• Actual Study Completion Date: December 2013

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• 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

Locations

United States, California

Abbott Vascular

Santa Clara, California, United States, 95054

Sponsors and Collaborators

Abbott Medical Devices

Investigators

• Principal Investigator: James Hermiller, MD; Heart Center of Indianapolis
• Principal Investigator: Mitch Krucoff, MD; Duke University

More Information

Additional Information:

NCT00676520 

NCT01106534 

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT01120379
• Other Study ID Numbers: 06-374B
• First Posted: May 10, 2010
• Results First Posted: October 11, 2013
• Last Update Posted: June 22, 2015
• Last Verified: May 2015

Keywords provided by Abbott Medical Devices:

drug eluting stents; Stents; Angioplasty; Stent thrombosis

Additional relevant MeSH terms:

Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Vascular Diseases; Coronary Stenosis; Coronary Occlusion; Coronary Restenosis; Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathologic Processes