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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01120379
First received: May 6, 2010
Last updated: December 11, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention
Chronic Coronary Occlusion
Vascular Disease
Myocardial Ischemia
Coronary Artery Stenosis
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
 Device: XIENCE V® EECSS

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • Stent thrombosis (definite and probable) as defined by ARC [ Time Frame: year 2 ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (definite and probable) as defined by ARC [ Time Frame: year 3 ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (definite and probable) as defined by ARC [ Time Frame: year 4 ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (definite and probable) as defined by ARC [ Time Frame: year 5 ] [ Designated as safety issue: Yes ]
  • Composite rate of cardiac death and any myocardial infarction [ Time Frame: year 2 ] [ Designated as safety issue: Yes ]
  • Composite rate of cardiac death and any myocardial infarction [ Time Frame: year 3 ] [ Designated as safety issue: Yes ]
  • Composite rate of cardiac death and any myocardial infarction [ Time Frame: year 4 ] [ Designated as safety issue: Yes ]
  • Composite rate of cardiac death and any myocardial infarction [ Time Frame: year 5 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Composite rate of all death and any MI (Q-wave and non Q-wave) [ Time Frame: Year 2 ] [ Designated as safety issue: Yes ]
  • 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: Year 2 ] [ Designated as safety issue: Yes ]
  • 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: Year 2 ] [ Designated as safety issue: Yes ]
  • Death (cardiac death, vascular death, and non-cardiovascular death) [ Time Frame: Year 2 ] [ Designated as safety issue: Yes ]
  • Any MI (Q-wave and non Q-wave) [ Time Frame: Year 2 ] [ Designated as safety issue: Yes ]
  • Revascularization (target lesion, target vessel [TVR], and non-target vessel) (PCI and CABG) [ Time Frame: Year 2 ] [ Designated as safety issue: No ]
  • Major bleeding complications [ Time Frame: Year 2 ] [ Designated as safety issue: Yes ]
  • Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy [ Time Frame: Year 2 ] [ Designated as safety issue: No ]
  • Composite rate of all death and any MI (Q-wave and non Q-wave) [ Time Frame: year 3 ] [ Designated as safety issue: Yes ]
  • Composite rate of all death and any MI (Q-wave and non Q-wave) [ Time Frame: year 4 ] [ Designated as safety issue: Yes ]
  • Composite rate of all death and any MI (Q-wave and non Q-wave) [ Time Frame: year 5 ] [ Designated as safety issue: Yes ]
  • 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: year 3 ] [ Designated as safety issue: Yes ]
  • 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: year 4 ] [ Designated as safety issue: Yes ]
  • 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: year 5 ] [ Designated as safety issue: Yes ]
  • 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: year 3 ] [ Designated as safety issue: Yes ]
  • 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: year 4 ] [ Designated as safety issue: Yes ]
  • 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: year 5 ] [ Designated as safety issue: Yes ]
  • Death (cardiac death, vascular death, and non-cardiovascular death) [ Time Frame: year 3 ] [ Designated as safety issue: Yes ]
  • Death (cardiac death, vascular death, and non-cardiovascular death) [ Time Frame: year 5 ] [ Designated as safety issue: Yes ]
  • Any MI (Q-wave and non Q-wave) [ Time Frame: year 3 ] [ Designated as safety issue: Yes ]
  • Any MI (Q-wave and non Q-wave) [ Time Frame: year 4 ] [ Designated as safety issue: Yes ]
  • Any MI (Q-wave and non Q-wave) [ Time Frame: year 5 ] [ Designated as safety issue: Yes ]
  • Revascularization (target lesion, target vessel [TVR], and non-target vessel) (PCI and CABG) [ Time Frame: year 3 ] [ Designated as safety issue: No ]
  • Revascularization (target lesion, target vessel [TVR], and non-target vessel) (PCI and CABG) [ Time Frame: year 4 ] [ Designated as safety issue: No ]
  • Revascularization (target lesion, target vessel [TVR], and non-target vessel) (PCI and CABG) [ Time Frame: year 5 ] [ Designated as safety issue: No ]
  • Major bleeding complications [ Time Frame: year 3 ] [ Designated as safety issue: Yes ]
  • Major bleeding complications [ Time Frame: year 4 ] [ Designated as safety issue: Yes ]
  • Major bleeding complications [ Time Frame: year 5 ] [ Designated as safety issue: Yes ]
  • Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy [ Time Frame: year 3 ] [ Designated as safety issue: No ]
  • Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy [ Time Frame: year 4 ] [ Designated as safety issue: No ]
  • Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy [ Time Frame: year 5 ] [ Designated as safety issue: No ]
  • 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: Year 2 ] [ Designated as safety issue: Yes ]
  • 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: year 3 ] [ Designated as safety issue: Yes ]
  • 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: year 4 ] [ Designated as safety issue: Yes ]
  • 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: year 5 ] [ Designated as safety issue: Yes ]
  • Death (cardiac death, vascular death, and non-cardiovascular death) [ Time Frame: year 4 ] [ Designated as safety issue: Yes ]

Enrollment: 5062
Study Start Date: July 2008
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01120379

Locations
United States, California
Abbott Vascular
Santa Clara, California, United States, 95054
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: James Hermiller, MD Heart Center of Indianapolis
Principal Investigator: Mitch Krucoff, MD Duke University
  More Information

Additional Information:
NCT00676520  This link exits the ClinicalTrials.gov site
NCT01106534  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01120379     History of Changes
Other Study ID Numbers: 06-374B
Study First Received: May 6, 2010
Last Updated: December 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott Vascular:
drug eluting stents
Stents
Angioplasty
Stent thrombosis

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Vascular Diseases
Coronary Occlusion
Coronary Stenosis
Coronary Restenosis
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Everolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013