Clinical trial NCT00676520: XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA-Phase 1)
Official title: XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) USA Post-Approval Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Angioplasty
Coronary Restenosis
Coronary Artery Disease
Coronary Artery Restenosis
Coronary Artery Stenosis
Total Artery Occlusion
Stents
Stent Thrombosis
Total Coronary Occlusion
Vascular Disease
Myocardial Ischemia
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2008-05-13
Enrollment: 8053
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: 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.

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 Constortium).
timeFrame: up to 1 year
measure: Composite Rate of Cardiac Death and Any Myocardial Infarction (MI)
timeFrame: 1 year
Secondary outcomes:
measure: Clinical Device Success
timeFrame: acute: post index procedure until hospital discharge
measure: Procedural Success
timeFrame: acute: post index procedure until hospital discharge
measure: Composite Rate of Cardiac Death and Any MI (Q-wave and Non Q-wave)
timeFrame: at 30 days
measure: Composite Rate of Cardiac Death and Any MI (Q-wave and Non Q-wave)
timeFrame: at 180 days
measure: Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)
timeFrame: at 30 days
measure: Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)
timeFrame: at 180 days
measure: Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)
timeFrame: at 1 year
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: at 30 days
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: at 180 days
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: at 1 year
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: at 30 days
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: at 180 days
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: at 1 year
measure: Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)
timeFrame: at 30 days
measure: Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)
timeFrame: at 180 days
measure: Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)
timeFrame: at 1 year
measure: Any MI (Q-wave and Non Q-wave)
timeFrame: at 30 days
measure: Any MI (Q-wave and Non Q-wave)
timeFrame: at 180 days
measure: Any MI (Q-wave and Non Q-wave)
timeFrame: at 1 year
measure: Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)
timeFrame: at 30 days
measure: Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)
timeFrame: at 180 days
measure: Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)
timeFrame: at 1 year
measure: Major Bleeding Complications
timeFrame: at 14 days
measure: Major Bleeding Complications
timeFrame: at 30 days
measure: Major Bleeding Complications
timeFrame: at 180 days
measure: Major Bleeding Complications
timeFrame: at 1 year
measure: Dual Antiplatelet Medication Usage
timeFrame: at 14 days
measure: Dual Antiplatelet Medication Usage
timeFrame: at 30 days
measure: Dual Antiplatelet Medication Usage
timeFrame: at 180 days
measure: Dual Antiplatelet Medication Usage
timeFrame: at 1 year
measure: Dual Antiplatelet Therapy Non-compliance Through 1 Year
timeFrame: 1 year
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: at 30 days
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: at 180 days
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: at 1 year
measure: Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire)
timeFrame: at baseline
measure: Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire)
timeFrame: at 180 days
measure: Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire)
timeFrame: at 1 year
measure: SAQ (Seattle Angina Questionaire)
timeFrame: at baseline
measure: SAQ (Seattle Angina Questionaire)
timeFrame: 180 days
measure: SAQ (Seattle Angina Questionaire)
timeFrame: 1 year
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:
citation: Genereux P, Rutledge DR, Palmerini T, Caixeta A, Kedhi E, Hermiller JB, Wang J, Krucoff MW, Jones-McMeans J, Sudhir K, Simonton CA, Serruys PW, Stone GW. Stent Thrombosis and Dual Antiplatelet Therapy Interruption With Everolimus-Eluting Stents: Insights From the Xience V Coronary Stent System Trials. Circ Cardiovasc Interv. 2015 May;8(5):e001362. doi: 10.1161/CIRCINTERVENTIONS.114.001362.
citation: Sudhir K, Hermiller JB, Naidu SS, Henry TD, Mao VW, Zhao W, Ferguson JM, Wang J, Jonnavithula L, Simonton CA, Rutledge DR, Krucoff MW; XIENCE V USA Investigators. Clinical outcomes in real-world patients with acute myocardial infarction receiving XIENCE V(R) everolimus-eluting stents: one-year results from the XIENCE V USA study. Catheter Cardiovasc Interv. 2013 Oct 1;82(4):E385-94. doi: 10.1002/ccd.24749. Epub 2013 Mar 28.
citation: Hermiller JB, Rutledge DR, Gruberg L, Katopodis JN, Lombardi W, Mao VW, Zhao W, Sharma SK, Tamboli HP, Wang J, Jonnavithula L, Sudhir K, Krucoff MW. Sustained low clinical event rates in real-world patients receiving everolimus-eluting coronary stent system from a large, prospective, condition of approval study: 2-year clinical outcomes from the XIENCE V USA Study. J Interv Cardiol. 2012 Dec;25(6):565-75. doi: 10.1111/j.1540-8183.2012.00766.x. Epub 2012 Sep 23.
citation: Naidu SS, Krucoff MW, Rutledge DR, Mao VW, Zhao W, Zheng Q, Wilburn O, Sudhir K, Simonton C, Hermiller JB. Contemporary incidence and predictors of stent thrombosis and other major adverse cardiac events in the year after XIENCE V implantation: results from the 8,061-patient XIENCE V United States study. JACC Cardiovasc Interv. 2012 Jun;5(6):626-35. doi: 10.1016/j.jcin.2012.02.014.
citation: Krucoff MW, Rutledge DR, Gruberg L, Jonnavithula L, Katopodis JN, Lombardi W, Mao VW, Sharma SK, Simonton CA, Tamboli HP, Wang J, Wilburn O, Zhao W, Sudhir K, Hermiller JB. A new era of prospective real-world safety evaluation primary report of XIENCE V USA (XIENCE V Everolimus Eluting Coronary Stent System condition-of-approval post-market study). JACC Cardiovasc Interv. 2011 Dec;4(12):1298-309. doi: 10.1016/j.jcin.2011.08.010.