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

NCT01120379 | Completed Results DMC

• 1 other identifier: 06-374B
• Study Type: observational
• Target: 5,034
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• Composite Rate of Cardiac Death and Any Myocardial Infarction [MI] (ARC Defined).

  2 years

• Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined).

  3 years

• Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined).

  4 years

Secondary Outcomes (27)

• Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)

  2 years

• Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)

  3 years

• Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)

  4 years

• 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

• 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

Study Arms (1)

XV-LTF cohort

Device: XIENCE V® EECSS

Interventions

XIENCE V® EECSS DEVICE

Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.

XV-LTF cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• The patient agrees to participate in this study by signing the Institutional Review Board approved informed consent form.

You may not qualify if:

• The inability to obtain an informed consent.
• Age limit is determined by investigator.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Abbott Vascular

Santa Clara, California, 95054, United States

Location

Related Links

• NCT00676520
• NCT01106534

MeSH Terms

Conditions

Vascular Diseases; Myocardial Ischemia; Coronary Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Results Point of Contact

• Title: Robert Smith Jr, Ph.D., Sr Clinical Research Scientist
• Organization: Abbott Vascular

robert.smithjr@av.abbott.com

408-845-8265

Study Officials

• James Hermiller, MD

  Heart Center of Indianapolis

  PRINCIPAL INVESTIGATOR

• Mitch Krucoff, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2010
• First Posted: May 10, 2010
• Study Start: July 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2013
• Last Updated: June 22, 2015
• Results First Posted: October 11, 2013

Record last verified: 2015-05

Locations

US (1)