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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) USA Post-Approval Study

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: XIENCE V® Everolimus Eluting Coronary Stent


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Single-arm study | Device: XIENCE V® Everolimus Eluting Coronary Stent<br>* Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Constortium). | 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 | up to 1 year | 
| Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) | MI= ARC (Academic Research Constortium) defined | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Device Success |  | acute: post index procedure until hospital discharge | 
| Procedural Success |  | acute: post index procedure until hospital discharge | 
| Composite Rate of Cardiac Death and Any MI (Q-wave and Non Q-wave) | MI= Academic Research Consortium (ARC) defined | at 30 days | 
| Composite Rate of Cardiac Death and Any MI (Q-wave and Non Q-wave) | MI= Academic Research Consortium (ARC) defined | at 180 days | 
| Composite Rate of All Death and Any MI (Q-wave and Non Q-wave) | MI= Academic Research Consortium (ARC) defined | at 30 days | 
| Composite Rate of All Death and Any MI (Q-wave and Non Q-wave) | MI= Academic Research Consortium (ARC) defined | at 180 days | 
| Composite Rate of All Death and Any MI (Q-wave and Non Q-wave) | MI= Academic Research Consortium (ARC) defined | at 1 year | 
| 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]) | MI= Academic Research Consortium (ARC) defined | at 30 days | 
| 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]) | MI= Academic Research Consortium (ARC) defined | at 180 days | 
| 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]) | MI= Academic Research Consortium (ARC) defined | at 1 year | 
| 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) | MI= Academic Research Consortium (ARC) defined | at 30 days | 
| 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) | MI= Academic Research Consortium (ARC) defined | at 180 days | 
| 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) | MI= Academic Research Consortium (ARC) defined | at 1 year | 
| Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death) |  | at 30 days | 
| Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death) |  | at 180 days | 
| Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death) |  | at 1 year | 
| Any MI (Q-wave and Non Q-wave) | MI= Academic Research Consortium (ARC) defined | at 30 days | 
| Any MI (Q-wave and Non Q-wave) | MI= Academic Research Consortium (ARC) defined | at 180 days | 
| Any MI (Q-wave and Non Q-wave) | MI= Academic Research Consortium (ARC) defined | at 1 year | 
| Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG) |  | at 30 days | 
| Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG) |  | at 180 days | 
| Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG) |  | at 1 year | 
| Major Bleeding Complications | by TIMI flow | at 14 days | 
| Major Bleeding Complications | by TIMI flow | at 30 days | 
| Major Bleeding Complications | by TIMI flow | at 180 days | 
| Major Bleeding Complications | by TIMI flow | at 1 year | 
| 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 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. | at 14 days | 
| 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 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. | at 30 days | 
| 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 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. | at 180 days | 
| 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 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. | at 1 year | 
| Dual Antiplatelet Therapy Non-compliance Through 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. | 1 year | 
| 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) | MI= Academic Research Consortium (ARC) defined | at 30 days | 
| 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) | MI= Academic Research Consortium (ARC) defined | at 180 days | 
| 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) | MI= Academic Research Consortium (ARC) defined | at 1 year | 
| Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire) | 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. | at baseline | 
| Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire) | 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. | at 180 days | 
| Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire) | 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. | at 1 year | 
| SAQ (Seattle Angina Questionaire) | 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. | at baseline | 
| SAQ (Seattle Angina Questionaire) | 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. | 180 days | 
| SAQ (Seattle Angina Questionaire) | 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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