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

Coronary Artery Disease Clinical Trial

— XVU-LTF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01120379
• Other study ID #: 06-374B
• Status: Completed
• Phase: N/A
• First received: May 6, 2010
• Last updated: May 26, 2015
• Start date: July 2008
• Est. completion date: December 2013

Study information

• Verified date: May 2015
• 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:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5034
• Est. completion date: December 2013
• Est. primary completion date: December 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

• Chronic Coronary Occlusion
• Coronary Artery Disease
• Coronary Artery Stenosis
• Coronary Disease
• Coronary Occlusion
• Coronary Restenosis
• Coronary Stenosis
• Myocardial Ischemia
• Vascular Disease
• Vascular Diseases

Intervention

Device:
• XIENCE V® EECSS
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 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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	Composite Rate of Cardiac Death and Any Myocardial Infarction [MI] (ARC Defined).		2 years	Yes
Primary	Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined).		3 years	Yes
Primary	Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined).		4 years	Yes
Secondary	Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)		2 years	Yes
Secondary	Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)		3 years	Yes
Secondary	Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)		4 years	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]		2 years	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]		3 years	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]		4 years	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)		2 years	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)		3 years	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)		4 years	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)		2 years	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)		3 years	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)		4 years	Yes
Secondary	Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)		2 years	Yes
Secondary	Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)		3 years	Yes
Secondary	Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)		4 years	Yes
Secondary	Any MI (Q-wave and Non Q-wave)		2 years	Yes
Secondary	Any MI (Q-wave and Non Q-wave)		3 years	Yes
Secondary	Any MI (Q-wave and Non Q-wave)		4 years	Yes
Secondary	Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)		2 years	No
Secondary	Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)		3 years	No
Secondary	Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)		4 years	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	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 2-year visit is 688-772 days.	2 years	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 3-year visit is 1053-1137 days.	3 years	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 4-year visit is 1502 days.	4 years	No

External Links

•   NCT00676520
•   NCT01106534