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

Coronary Artery Disease Clinical Trial

— XVU-Phase 1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00676520
• Other study ID #: 06-374
• Status: Completed
• Phase: Phase 4
• First received: October 16, 2007
• Last updated: October 10, 2012
• Start date: July 2008
• Est. completion date: March 2011

Study information

• Verified date: October 2012
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8053
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
United States	Abbott Vascular	Santa Clara	California

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Composite Rate of Cardiac Death and Any Myocardial Infarction (MI)	MI= ARC (Academic Research Constortium) defined	1 year	Yes
Secondary	Clinical Device Success		acute: post index procedure until hospital discharge	No
Secondary	Procedural Success		acute: post index procedure until hospital discharge	No
Secondary	Composite Rate of Cardiac Death and Any MI (Q-wave and Non Q-wave)	MI= Academic Research Consortium (ARC) defined	at 30 days	Yes
Secondary	Composite Rate of Cardiac Death and Any MI (Q-wave and Non Q-wave)	MI= Academic Research Consortium (ARC) defined	at 180 days	Yes
Secondary	Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)	MI= Academic Research Consortium (ARC) defined	at 30 days	Yes
Secondary	Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)	MI= Academic Research Consortium (ARC) defined	at 180 days	Yes
Secondary	Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)	MI= Academic Research Consortium (ARC) defined	at 1 year	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)		at 30 days	Yes
Secondary	Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)		at 180 days	Yes
Secondary	Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)		at 1 year	Yes
Secondary	Any MI (Q-wave and Non Q-wave)	MI= Academic Research Consortium (ARC) defined	at 30 days	Yes
Secondary	Any MI (Q-wave and Non Q-wave)	MI= Academic Research Consortium (ARC) defined	at 180 days	Yes
Secondary	Any MI (Q-wave and Non Q-wave)	MI= Academic Research Consortium (ARC) defined	at 1 year	Yes
Secondary	Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)		at 30 days	Yes
Secondary	Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)		at 180 days	Yes
Secondary	Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)		at 1 year	Yes
Secondary	Major Bleeding Complications	by TIMI flow	at 14 days	Yes
Secondary	Major Bleeding Complications	by TIMI flow	at 30 days	Yes
Secondary	Major Bleeding Complications	by TIMI flow	at 180 days	Yes
Secondary	Major Bleeding Complications	by TIMI flow	at 1 year	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No