Clinical trial NCT01120379: XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA Long Term Follow-up Cohort)
Official title: XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) USA Post-Approval Study (XIENCE V® USA Long Term Follow-up Cohort)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Coronary Occlusion
Vascular Disease
Myocardial Ischemia
Coronary Artery Stenosis
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Keywords: drug eluting stents
Stents
Angioplasty
Stent thrombosis
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2010-05-10
Enrollment: 5034
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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.

Primary outcomes:
measure: Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Consortium)
timeFrame: 2 years
measure: Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Consortium)
timeFrame: 3 years
measure: Stent Thrombosis (Definite and Probable) as Defined by ARC
timeFrame: 4 years
measure: Composite Rate of Cardiac Death and Any Myocardial Infarction [MI] (ARC Defined).
timeFrame: 2 years
measure: Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined).
timeFrame: 3 years
measure: Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined).
timeFrame: 4 years
Secondary outcomes:
measure: Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)
timeFrame: 2 years
measure: Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)
timeFrame: 3 years
measure: Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)
timeFrame: 4 years
measure: 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]
timeFrame: 2 years
measure: 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]
timeFrame: 3 years
measure: 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]
timeFrame: 4 years
measure: 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)
timeFrame: 2 years
measure: 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)
timeFrame: 3 years
measure: 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)
timeFrame: 4 years
measure: 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)
timeFrame: 2 years
measure: 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)
timeFrame: 3 years
measure: 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)
timeFrame: 4 years
measure: Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)
timeFrame: 2 years
measure: Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)
timeFrame: 3 years
measure: Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)
timeFrame: 4 years
measure: Any MI (Q-wave and Non Q-wave)
timeFrame: 2 years
measure: Any MI (Q-wave and Non Q-wave)
timeFrame: 3 years
measure: Any MI (Q-wave and Non Q-wave)
timeFrame: 4 years
measure: Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)
timeFrame: 2 years
measure: Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)
timeFrame: 3 years
measure: Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)
timeFrame: 4 years
measure: Major Bleeding Complications
timeFrame: 2 years
measure: Major Bleeding Complications (Site Reported)
timeFrame: 3 years
measure: Major Bleeding Complications
timeFrame: 4 years
measure: Dual Antiplatelet Medication Usage
timeFrame: 2 years
measure: Dual Antiplatelet Medication Usage
timeFrame: 3 years
measure: Dual Antiplatelet Medication Usage
timeFrame: 4 years
Other outcomes:
Locations:
city: Santa Clara
country: United States
facility: Abbott Vascular
state: California
Study officials:
affiliation: Heart Center of Indianapolis
name: James Hermiller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Mitch Krucoff, MD
role: PRINCIPAL_INVESTIGATOR
References: