Coronary Artery DiseaseXVU-Phase 1NCT00676520
XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA-Phase 1)
An observational study of Coronary Artery Disease, run by Abbott Medical Devices at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- XIENCE V® Everolimus Eluting Coronary Stent
- Type of treatment
- Medical device
- How many people
- 8,053 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Mar 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- The patient agrees to participate in this study by signing the Institutional Review Board approved informed consent form.
Who cannot join
- The inability to obtain an informed consent.
- Age limit is determined by investigator.
- There are no angiographic inclusion or exclusion criteria for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) USA Post-Approval Study
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- XIENCE V® Everolimus Eluting Coronary Stent
- 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
- Medical subject headings
- Coronary Artery Disease, Coronary Restenosis, Coronary Stenosis, Vascular Diseases, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XIENCE V® Everolimus Eluting Coronary StentDevice
Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Single-arm study Receives: Device: XIENCE V® Everolimus Eluting Coronary Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Constortium).
ARC Defines Stent Thrombosis in the following way:
Definite Stent Thrombosis: Angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region AND at least ONE of the following, additional criteria:
Acute ischemic symptoms Ischemic ECG changes Elevated cardiac biomarkers
Probable Stent Thrombosis: Any unexplained death within 30 days of stent implantation or any myocardial infarction, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause
Possible Stent Thrombosis Any unexplained death beyond 30 days
For further information on ARC definitions, please refer to the following website: http://circ.ahajournals.org/content/115/17/2344.full#sec-1
Measured: up to 1 year
Composite Rate of Cardiac Death and Any Myocardial Infarction (MI)
MI= ARC (Academic Research Constortium) defined
Measured: 1 year
Secondary outcomes (40)
Clinical Device Success
Measured: acute: post index procedure until hospital discharge
Procedural Success
Measured: acute: post index procedure until hospital discharge
Composite Rate of Cardiac Death and Any MI (Q-wave and Non Q-wave)
MI= Academic Research Consortium (ARC) defined
Measured: at 30 days
Composite Rate of Cardiac Death and Any MI (Q-wave and Non Q-wave)
MI= Academic Research Consortium (ARC) defined
Measured: at 180 days
Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)
MI= Academic Research Consortium (ARC) defined
Measured: at 30 days
Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)
MI= Academic Research Consortium (ARC) defined
Measured: at 180 days
Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)
MI= Academic Research Consortium (ARC) defined
Measured: at 1 year
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])
MI= Academic Research Consortium (ARC) defined
Measured: at 30 days
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])
MI= Academic Research Consortium (ARC) defined
Measured: at 180 days
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])
MI= Academic Research Consortium (ARC) defined
Measured: at 1 year
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)
MI= Academic Research Consortium (ARC) defined
Measured: at 30 days
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)
MI= Academic Research Consortium (ARC) defined
Measured: at 180 days
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)
MI= Academic Research Consortium (ARC) defined
Measured: at 1 year
Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)
Measured: at 30 days
Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)
Measured: at 180 days
Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)
Measured: at 1 year
Any MI (Q-wave and Non Q-wave)
MI= Academic Research Consortium (ARC) defined
Measured: at 30 days
Any MI (Q-wave and Non Q-wave)
MI= Academic Research Consortium (ARC) defined
Measured: at 180 days
Any MI (Q-wave and Non Q-wave)
MI= Academic Research Consortium (ARC) defined
Measured: at 1 year
Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)
Measured: at 30 days
Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)
Measured: at 180 days
Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)
Measured: at 1 year
Major Bleeding Complications
by TIMI flow
Measured: at 14 days
Major Bleeding Complications
by TIMI flow
Measured: at 30 days
Major Bleeding Complications
by TIMI flow
Measured: at 180 days
Major Bleeding Complications
by TIMI flow
Measured: at 1 year
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 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days.
Adjunctive antiplatelet therapy includes: Aspirin \& Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel).
Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications.
Measured: at 14 days
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 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days.
Adjunctive antiplatelet therapy includes: Aspirin \& Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel).
Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications.
Measured: at 30 days
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 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days.
Adjunctive antiplatelet therapy includes: Aspirin \& Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel).
Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications.
Measured: at 180 days
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 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days.
Adjunctive antiplatelet therapy includes: Aspirin \& Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel).
Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications.
Measured: at 1 year
Dual Antiplatelet Therapy Non-compliance Through 1 Year
Defined as patients who had at least 1 day without using either aspirin or thienopyridine from 1 to 407 days post index procedure.
Measured: 1 year
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)
MI= Academic Research Consortium (ARC) defined
Measured: at 30 days
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)
MI= Academic Research Consortium (ARC) defined
Measured: at 180 days
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)
MI= Academic Research Consortium (ARC) defined
Measured: at 1 year
Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire)
SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:
Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do.
Treatment Satisfaction: how well a patient understands her care and what she thinks of it.
Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind.
Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100.
Measured: at baseline
Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire)
SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:
Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do.
Treatment Satisfaction: how well a patient understands her care and what she thinks of it.
Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind.
Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100.
Measured: at 180 days
Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire)
SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:
Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do.
Treatment Satisfaction: how well a patient understands her care and what she thinks of it.
Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind.
Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100.
Measured: at 1 year
SAQ (Seattle Angina Questionaire)
SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:
Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do.
Treatment Satisfaction: how well a patient understands her care and what she thinks of it.
Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind.
Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100.
Measured: at baseline
SAQ (Seattle Angina Questionaire)
SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:
Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do.
Treatment Satisfaction: how well a patient understands her care and what she thinks of it.
Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind.
Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100.
Measured: 180 days
SAQ (Seattle Angina Questionaire)
SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:
Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do.
Treatment Satisfaction: how well a patient understands her care and what she thinks of it.
Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind.
Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,053 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Hermiller, MD, Principal investigator, Heart Center of IndianapolisMitch Krucoff, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676520
- Sponsor's protocol ID
- 06-374
- Acronym
- XVU-Phase 1
- Status last verified
- Oct 2012
- First submitted
- 16 Oct 2007
- Last updated
- 20 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 25940520Sudhir 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.
PubMed 23172848Hermiller 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.
PubMed 22998355Naidu 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.
PubMed 22721657Krucoff 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.
PubMed 22192371
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) USA Post-Approval Study
- ClinicalTrials.gov ID
- NCT00676520
- Acronym / sponsor ID
- XVU-Phase 1 / 06-374
- Conditions
- Coronary Artery Disease
- Keywords
- Angioplasty, Coronary Restenosis, Coronary Artery Disease, Coronary Artery Restenosis, Coronary Artery Stenosis, Total Artery Occlusion, Stents, Stent Thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,053 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 13 May 2008 (estimated)
- Results
- Posted 20 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: XIENCE V® Everolimus Eluting Coronary StentSingle-arm study |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- The patient agrees to participate in this study by signing the Institutional Review Board approved informed consent form.
Key exclusion criteria (3 listed)
- The inability to obtain an informed consent.
- Age limit is determined by investigator.
- There are no angiographic inclusion or exclusion criteria for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XIENCE V® Everolimus Eluting Coronary StentSingle-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings. | Device | 1 |
Primary outcome
Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Constortium).
Time frame: up to 1 year
ARC Defines Stent Thrombosis in the following way: Definite Stent Thrombosis: Angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region AND at least ONE of the following, additional criteria: Acute ischemic symptoms Ischemic ECG changes Elevated cardiac biomarkers Probable Stent Thrombosis: Any unexplained death within 30 days of stent implantation or any myocardial infarction, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause Possible Stent Thrombosis Any unexplained death beyond 30 days For further information on ARC definitions, please refer to the following website: http://circ.ahajournals.org/content/115/17/2344.full#sec-1
Composite Rate of Cardiac Death and Any Myocardial Infarction (MI)
Time frame: 1 year
MI= ARC (Academic Research Constortium) defined
40 secondary outcomes
Clinical Device Success
Time frame: acute: post index procedure until hospital discharge
Procedural Success
Time frame: acute: post index procedure until hospital discharge
Composite Rate of Cardiac Death and Any MI (Q-wave and Non Q-wave)
Time frame: at 30 days
Composite Rate of Cardiac Death and Any MI (Q-wave and Non Q-wave)
Time frame: at 180 days
Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)
Time frame: at 30 days
Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)
Time frame: at 180 days
Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)
Time frame: at 1 year
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: at 30 days
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: at 180 days
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: at 1 year
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: at 30 days
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: at 180 days
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: at 1 year
Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)
Time frame: at 30 days
Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)
Time frame: at 180 days
Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)
Time frame: at 1 year
Any MI (Q-wave and Non Q-wave)
Time frame: at 30 days
Any MI (Q-wave and Non Q-wave)
Time frame: at 180 days
Any MI (Q-wave and Non Q-wave)
Time frame: at 1 year
Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)
Time frame: at 30 days
Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)
Time frame: at 180 days
Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)
Time frame: at 1 year
Major Bleeding Complications
Time frame: at 14 days
Major Bleeding Complications
Time frame: at 30 days
Major Bleeding Complications
Time frame: at 180 days
Major Bleeding Complications
Time frame: at 1 year
Dual Antiplatelet Medication Usage
Time frame: at 14 days
Dual Antiplatelet Medication Usage
Time frame: at 30 days
Dual Antiplatelet Medication Usage
Time frame: at 180 days
Dual Antiplatelet Medication Usage
Time frame: at 1 year
Dual Antiplatelet Therapy Non-compliance Through 1 Year
Time frame: 1 year
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: at 30 days
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: at 180 days
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: at 1 year
Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire)
Time frame: at baseline
Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire)
Time frame: at 180 days
Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire)
Time frame: at 1 year
SAQ (Seattle Angina Questionaire)
Time frame: at baseline
SAQ (Seattle Angina Questionaire)
Time frame: 180 days
SAQ (Seattle Angina Questionaire)
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25940520Genereux 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.
- Derived from this study: PubMed 23172848Sudhir 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.
- Derived from this study: PubMed 22998355Hermiller 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.
- Derived from this study: PubMed 22721657Naidu 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.
- Derived from this study: PubMed 22192371Krucoff 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Hermiller, MD principal investigator
Heart Center of Indianapolis
Mitch Krucoff, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Abbott Medical Devices at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Constortium). (time frame: up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00676520, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2012.