Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

XIENCE 28 USA Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03815175
Recruitment Status : Completed
First Posted : January 24, 2019
Results First Posted : December 14, 2021
Last Update Posted : May 3, 2022
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
The XIENCE 28 USA Study is prospective, single arm, multi-center, open label, non-randomized trial to evaluate safety of 1-month (as short as 28 days) dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary intervention (PCI) with the approved XIENCE family (XIENCE Xpedition Everolimus Eluting Coronary Stent System [EECSS], XIENCE Alpine EECSS and XIENCE Sierra EECSS) of coronary drug-eluting stents.

Condition or disease Intervention/treatment Phase
Bleeding Disorder Ischemic Stroke Hemorrhagic Stroke Hematological Diseases Thrombocytopenia Coagulation Disorder Anemia Renal Insufficiency Coronary Artery Disease Device: XIENCE Drug: DAPT (aspirin and/or P2Y12 receptor inhibitor) Not Applicable

Detailed Description:

The XIENCE 28 USA Study will evaluate the safety of 1-month DAPT following XIENCE implantation in HBR patients. A minimum of 640 to a maximum of 800 subjects will be registered from approximately 50 sites in the United States and Canada. Subject registration is capped at 75 per site. Eligibility of P2Y12 receptor inhibitor discontinuation will be assessed at 1-month follow-up. Subjects who are free from myocardial infarction (MI), repeat coronary revascularization, stroke, or stent thrombosis (ARC definite/probable) within 1 month (prior to 1-month visit but at least 28 days) after stenting AND have been compliant with 1-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days are considered as "1-month clear", and will discontinue P2Y12 receptor inhibitor as early as 28 days and continued with aspirin monotherapy through 12-month follow-up.

All registered subjects will be followed at 1, 3, 6 and 12 months post index procedure. The data collected from the XIENCE 28 USA Study will be pooled with the data from the XIENCE 28 Global Study (Protocol # ABT-CIP-10235) to compare with the historical control of non-complex HBR subjects treated with standard DAPT duration of up to 12 months from the XIENCE V USA Study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1605 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: XIENCE 28 USA Study
Actual Study Start Date : February 25, 2019
Actual Primary Completion Date : August 14, 2020
Actual Study Completion Date : February 4, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: XIENCE
XIENCE + 1 month DAPT
Device: XIENCE
Subjects who received XIENCE family stent systems will be included.

Drug: DAPT (aspirin and/or P2Y12 receptor inhibitor)
"1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Other Name: Dual antiplatelet therapy




Primary Outcome Measures :
  1. Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (MI) (Modified Academic Research Consortium [ARC]), by Propensity Score Quintile [ Time Frame: From 1 to 6 months ]

    All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.

    MI Definition (Modified ARC):

    Patients present any of the following clinical or imaging evidence of ischemia:

    • Clinical symptoms of ischemia;
    • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
    • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality

    AND confirmed with elevated cardiac biomarkers per ARC criteria:

    • Peripheral MI
    • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

  2. Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile [ Time Frame: From 6 to 12 months ]

    All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.

    MI Definition (Modified ARC):

    Patients present any of the following clinical or imaging evidence of ischemia:

    • Clinical symptoms of ischemia;
    • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
    • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality

    AND confirmed with elevated cardiac biomarkers per ARC criteria:

    • Peripheral MI
    • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

  3. Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile [ Time Frame: From 1 to 12 months ]

    All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.

    MI Definition (Modified ARC):

    Patients present any of the following clinical or imaging evidence of ischemia:

    • Clinical symptoms of ischemia;
    • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
    • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality

    AND confirmed with elevated cardiac biomarkers per ARC criteria:

    • Peripheral MI
    • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL


Secondary Outcome Measures :
  1. Percentage of Participants With Major Bleeding Rate (Bleeding Academic Research Consortium [BARC] Type 2-5), by Propensity Score Quintiles [ Time Frame: From 1 to 6 months ]

    Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions:

    • Type 2: Any overt, actionable sign of hemorrhage
    • Type 3a: Overt bleeding plus Hb drop of 3 to < 5g/dL;Any transfusion with overt bleeding
    • Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL;Cardiac tamponade;Bleeding requiring surgical intervention for control;Bleeding requiring IV vasoactive agents
    • Type 3c: Intracranial hemorrhage; Subcategories confirmed by autopsy/imaging/lumbar puncture;Intraocular bleed compromising vision
    • Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48h;Reoperation after closure of sternotomy for the purpose of controlling bleeding;Transfusion of ≥ 5 U whole blood/packed red blood cells within a 48h period;Chest tube output ≥ 2L within 24-h period
    • Type 5: Fatal bleeding
    • Type 5a: Probable fatal bleeding;no autopsy/imaging confirmation but clinically suspicious
    • Type 5b: Definite fatal bleeding;overt bleeding/autopsy/imaging confirmation

  2. Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles [ Time Frame: From 6 to 12 months ]

    Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions:

    • Type 2: Any overt, actionable sign of hemorrhage
    • Type 3a: Overt bleeding plus Hb drop of 3 to < 5g/dL;Any transfusion with overt bleeding
    • Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL;Cardiac tamponade;Bleeding requiring surgical intervention for control;Bleeding requiring IV vasoactive agents
    • Type 3c: Intracranial hemorrhage; Subcategories confirmed by autopsy/imaging/lumbar puncture;Intraocular bleed compromising vision
    • Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48h;Reoperation after closure of sternotomy for the purpose of controlling bleeding;Transfusion of ≥ 5 U whole blood/packed red blood cells within a 48h period;Chest tube output ≥ 2L within 24-h period
    • Type 5: Fatal bleeding
    • Type 5a: Probable fatal bleeding;no autopsy/imaging confirmation but clinically suspicious
    • Type 5b: Definite fatal bleeding;overt bleeding/autopsy/imaging confirmation

  3. Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles [ Time Frame: From 1 to 12 months ]

    Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions:

    • Type 2: Any overt, actionable sign of hemorrhage
    • Type 3a: Overt bleeding plus Hb drop of 3 to < 5g/dL;Any transfusion with overt bleeding
    • Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL;Cardiac tamponade;Bleeding requiring surgical intervention for control;Bleeding requiring IV vasoactive agents
    • Type 3c: Intracranial hemorrhage; Subcategories confirmed by autopsy/imaging/lumbar puncture;Intraocular bleed compromising vision
    • Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48h;Reoperation after closure of sternotomy for the purpose of controlling bleeding;Transfusion of ≥ 5 U whole blood/packed red blood cells within a 48h period;Chest tube output ≥ 2L within 24-h period
    • Type 5: Fatal bleeding
    • Type 5a: Probable fatal bleeding;no autopsy/imaging confirmation but clinically suspicious
    • Type 5b: Definite fatal bleeding;overt bleeding/autopsy/imaging confirmation

  4. Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite) [ Time Frame: From 1 to 6 months ]

    Definite stent thrombosis:

    Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

    Probable stent thrombosis:

    Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:

    • Any unexplained death within the first 30 days
    • Irrespective of the time after the index procedure, any MI that 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

  5. Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite) [ Time Frame: From 6 to 12 months ]

    Definite stent thrombosis:

    Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

    Probable stent thrombosis:

    Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:

    • Any unexplained death within the first 30 days
    • Irrespective of the time after the index procedure, any MI that 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

  6. Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite) [ Time Frame: From 1 to 12 months ]

    Definite stent thrombosis:

    Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

    Probable stent thrombosis:

    Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:

    • Any unexplained death within the first 30 days
    • Irrespective of the time after the index procedure, any MI that 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

  7. Number of All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death) [ Time Frame: From 1 to 6 months ]

    All Death:

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even inpatients with coexisting potentially fatal non-cardiac disease (e.g. cancer,infection) should be classified as cardiac.

    Cardiac death:

    Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death:

    Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death:

    Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.


  8. Number of All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death) [ Time Frame: From 6 to 12 months ]

    All Death:

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even inpatients with coexisting potentially fatal non-cardiac disease (e.g. cancer,infection) should be classified as cardiac.

    Cardiac death:

    Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death:

    Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death:

    Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.


  9. Number of All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death) [ Time Frame: From 1 to 12 months ]

    All Death:

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even inpatients with coexisting potentially fatal non-cardiac disease (e.g. cancer,infection) should be classified as cardiac.

    Cardiac death:

    Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death:

    Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death:

    Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.


  10. Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC) [ Time Frame: From 1 to 6 months ]

    All Myocardial Infarction (Modified ARC):

    Patients present any of the following clinical or imaging evidence of ischemia:

    • Clinical symptoms of ischemia;
    • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
    • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)

    AND confirmed with elevated cardiac biomarkers per ARC criteria:

    • Periprocedural MI:

      • Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL
      • Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
    • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

    TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.


  11. Number of Participants With All MI and MI Attributed to Target Vessel (TV-MI, Modified ARC) [ Time Frame: From 6 to 12 months ]

    All Myocardial Infarction (Modified ARC):

    Patients present any of the following clinical or imaging evidence of ischemia:

    • Clinical symptoms of ischemia;
    • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
    • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)

    AND confirmed with elevated cardiac biomarkers per ARC criteria:

    • Periprocedural MI:

      • Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL
      • Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
    • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

    TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.


  12. Number of Participants With All MI and MI Attributed to Target Vessel (TV-MI, Modified ARC) [ Time Frame: From 1 to 12 months ]

    All Myocardial Infarction (Modified ARC):

    Patients present any of the following clinical or imaging evidence of ischemia:

    • Clinical symptoms of ischemia;
    • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
    • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)

    AND confirmed with elevated cardiac biomarkers per ARC criteria:

    • Periprocedural MI:

      • Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL
      • Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
    • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

    TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.


  13. Number of Participants With Composite of Cardiac Death or MI (Modified ARC) [ Time Frame: From 1 to 6 months ]

    Cardiac death:

    Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    MI (Modified ARC):

    Patients present any of the following clinical or imaging evidence of ischemia:

    • Clinical symptoms of ischemia;
    • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
    • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality

    AND confirmed with elevated cardiac biomarkers per ARC criteria:

    • Periprocedural MI:

      • Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URLwith baseline value < URL
      • Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
    • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

  14. Number of Participants With Composite of Cardiac Death or MI (Modified ARC) [ Time Frame: From 6 to 12 months ]

    Cardiac death:

    Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    MI (Modified ARC):

    Patients present any of the following clinical or imaging evidence of ischemia:

    • Clinical symptoms of ischemia;
    • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
    • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality

    AND confirmed with elevated cardiac biomarkers per ARC criteria:

    • Periprocedural MI:

      • Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URLwith baseline value < URL
      • Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
    • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

  15. Number of Participants With Composite of Cardiac Death or MI (Modified ARC) [ Time Frame: From 1 to 12 months ]

    Cardiac death:

    Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    MI (Modified ARC):

    Patients present any of the following clinical or imaging evidence of ischemia:

    • Clinical symptoms of ischemia;
    • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
    • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality

    AND confirmed with elevated cardiac biomarkers per ARC criteria:

    • Periprocedural MI:

      • Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URLwith baseline value < URL
      • Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
    • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

  16. Number of Participants With Composite of All Death or All MI (Modified ARC) [ Time Frame: From 1 to 6 months ]

    All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.

    MI (Modified ARC):

    Patients present any of the following clinical or imaging evidence of ischemia:

    • Clinical symptoms of ischemia;
    • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
    • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)

    AND confirmed with elevated cardiac biomarkers per ARC criteria:

    • Periprocedural MI
    • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

  17. Number of Participants With Composite of All Death or All MI (Modified ARC) [ Time Frame: From 6 to 12 months ]

    All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.

    MI (Modified ARC):

    Patients present any of the following clinical or imaging evidence of ischemia:

    • Clinical symptoms of ischemia;
    • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
    • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)

    AND confirmed with elevated cardiac biomarkers per ARC criteria:

    • Periprocedural MI
    • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

  18. Number of Participants With Composite of All Death or All MI (Modified ARC) [ Time Frame: From 1 to 12 months ]

    All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.

    MI (Modified ARC):

    Patients present any of the following clinical or imaging evidence of ischemia:

    • Clinical symptoms of ischemia;
    • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
    • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)

    AND confirmed with elevated cardiac biomarkers per ARC criteria:

    • Periprocedural MI
    • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

  19. Number of Participants With All Stroke (Ischemic Stroke and Hemorrhagic Stroke) [ Time Frame: From 1 to 6 months ]

    An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.

    • Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.
    • Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage.
    • Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic.
    • Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)

  20. Number of Participants With All Stroke (Ischemic Stroke and Hemorrhagic Stroke) [ Time Frame: From 6 to 12 months ]

    An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.

    • Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.
    • Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage.
    • Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic.
    • Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)

  21. Number of Participants With All Stroke (Ischemic Stroke and Hemorrhagic Stroke) [ Time Frame: From 1 to 12 months ]

    An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.

    • Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.
    • Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage.
    • Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic.
    • Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)

  22. Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR) [ Time Frame: From 1 to 6 months ]

    Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography.

    Clinically Indicated [CI] Revascularization:

    A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:

    • A positive history of recurrent angina pectoris, presumably related to the target vessel;
    • Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
    • Abnormal results of any invasive functional diagnostic test
    • A TLR/TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.

  23. Number of Participants With CI-TLR [ Time Frame: From 6 to 12 months ]

    Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography.

    Clinically Indicated [CI] Revascularization:

    A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:

    • A positive history of recurrent angina pectoris, presumably related to the target vessel;
    • Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
    • Abnormal results of any invasive functional diagnostic test
    • A TLR/TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.

  24. Number of Participants With CI-TLR [ Time Frame: From 1 to 12 months ]

    Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography.

    Clinically Indicated [CI] Revascularization:

    A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:

    • A positive history of recurrent angina pectoris, presumably related to the target vessel;
    • Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
    • Abnormal results of any invasive functional diagnostic test
    • A TLR/TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.

  25. Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR) [ Time Frame: From 1 to 6 months ]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:

    • A positive history of recurrent angina pectoris, presumably related to the target vessel;
    • Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
    • Abnormal results of any invasive functional diagnostic test (e.g.,Doppler flow velocity reserve, fractional flow reserve);
    • A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.

  26. Number of Participants With CI-TVR [ Time Frame: From 6 to 12 months ]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:

    • A positive history of recurrent angina pectoris, presumably related to the target vessel;
    • Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
    • Abnormal results of any invasive functional diagnostic test (e.g.,Doppler flow velocity reserve, fractional flow reserve);
    • A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.

  27. Number of Participants With CI-TVR [ Time Frame: From 1 to 12 months ]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:

    • A positive history of recurrent angina pectoris, presumably related to the target vessel;
    • Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
    • Abnormal results of any invasive functional diagnostic test (e.g.,Doppler flow velocity reserve, fractional flow reserve);
    • A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.

  28. Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR) [ Time Frame: From 1 to 6 months ]
    TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.

  29. Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR) [ Time Frame: From 6 to 12 months ]
    TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.

  30. Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR) [ Time Frame: From 1 to 12 months ]
    TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.

  31. Number of Participants With Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI and CI-TVR) [ Time Frame: From 1 to 6 months ]
    TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.

  32. Number of Participants With Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI and CI-TVR) [ Time Frame: From 6 to 12 months ]
    TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.

  33. Number of Participants With Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI and CI-TVR) [ Time Frame: From 1 to 12 months ]
    TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.

  34. Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5 [ Time Frame: From 1 to 6 months ]

    Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows:

    • Type 3a: Overt bleeding plus Hemoglobin(Hb) drop of 3 to < 5 g/dL; Any transfusion with overt bleeding
    • Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL; Cardiac tamponade; Bleeding requiring surgical intervention for control; Bleeding requiring IV vasoactive agents
    • Type 3c: Intracranial hemorrhage;Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed compromising vision
    • Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48 h; Reoperation after closure of sternotomy for the purpose of controlling bleeding; Transfusion of ≥ 5 U whole blood or packed red blood cells within a 48-h period; Chest tube output ≥ 2L within a 24-h period
    • Type 5: Fatal bleeding
    • Type 5a: Probable fatal bleeding; no autopsy/imaging confirmation but clinically suspicious
    • Type 5b: Definite fatal bleeding;overt bleeding/autopsy or imaging confirmation

  35. Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5 [ Time Frame: From 6 to 12 months ]

    Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows:

    • Type 3a: Overt bleeding plus Hemoglobin(Hb) drop of 3 to < 5 g/dL; Any transfusion with overt bleeding
    • Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL; Cardiac tamponade; Bleeding requiring surgical intervention for control; Bleeding requiring IV vasoactive agents
    • Type 3c: Intracranial hemorrhage;Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed compromising vision
    • Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48 h; Reoperation after closure of sternotomy for the purpose of controlling bleeding; Transfusion of ≥ 5 U whole blood or packed red blood cells within a 48-h period; Chest tube output ≥ 2L within a 24-h period
    • Type 5: Fatal bleeding
    • Type 5a: Probable fatal bleeding; no autopsy/imaging confirmation but clinically suspicious
    • Type 5b: Definite fatal bleeding;overt bleeding/autopsy or imaging confirmation

  36. Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5 [ Time Frame: From 1 to 12 months ]

    Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows:

    • Type 3a: Overt bleeding plus Hemoglobin(Hb) drop of 3 to < 5 g/dL; Any transfusion with overt bleeding
    • Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL; Cardiac tamponade; Bleeding requiring surgical intervention for control; Bleeding requiring IV vasoactive agents
    • Type 3c: Intracranial hemorrhage;Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed compromising vision
    • Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48 h; Reoperation after closure of sternotomy for the purpose of controlling bleeding; Transfusion of ≥ 5 U whole blood or packed red blood cells within a 48-h period; Chest tube output ≥ 2L within a 24-h period
    • Type 5: Fatal bleeding
    • Type 5a: Probable fatal bleeding; no autopsy/imaging confirmation but clinically suspicious
    • Type 5b: Definite fatal bleeding;overt bleeding/autopsy or imaging confirmation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is considered at high risk for bleeding (HBR), defined as meeting one or more of the following criteria at the time of registration and in the opinion of the referring physician, the risk of major bleeding with > 1-month DAPT outweighs the benefit:

    1. ≥ 75 years of age.
    2. Clinical indication for chronic (at least 6 months) or lifelong anticoagulation therapy
    3. History of major bleeding which required medical attention within 12 months of the index procedure.
    4. History of stroke (ischemic or hemorrhagic).
    5. Renal insufficiency (creatinine ≥ 2.0 mg/dl) or failure (dialysis dependent).
    6. Systemic conditions associated with an increased bleeding risk (e.g. hematological disorders, including a history of or current thrombocytopenia defined as a platelet count <100,000/mm3, or any known coagulation disorder associated with increased bleeding risk).
    7. Anemia with hemoglobin < 11g/dl.
  2. Subject must be at least 18 years of age.
  3. Subject must provide written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site prior to any trial related procedure.
  4. Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at 1 month, if eligible per protocol.
  5. Subject must agree not to participate in any other clinical trial for a period of one year following the index procedure, except for cases where subject is transferred to the XIENCE 90 study after the 1-month visit assessment

Angiographic Inclusion Criteria

  1. Up to three target lesions with a maximum of two target lesions per epicardial vessel. Note:

    • The definition of epicardial vessels means left anterior descending coronary artery (LAD), left circumflex coronary artery (LCX) and right coronary artery (RCA) and their branches. For example, the subject must not have >2 lesions requiring treatment within both the LAD and a diagonal branch in total.
    • If there are two target lesions within the same epicardial vessel, the two target lesions must be at least 15 mm apart per visual estimation; otherwise this is considered as a single target lesion.
  2. Target lesion must be located in a native coronary artery with visually estimated reference vessel diameter between 2.25 mm and 4.25 mm.
  3. Exclusive use of XIENCE family of stent systems during the index procedure.
  4. Target lesion has been treated successfully, which is defined as achievement of a final in-stent residual diameter stenosis of <20% with final TIMI-3 flow assessed by online quantitative angiography or visual estimation, with no residual dissection NHLBI grade ≥ type B, and no transient or sustained angiographic complications (e.g., distal embolization, side branch closure), no chest pain lasting > 5 minutes, and no ST segment elevation > 0.5mm or depression lasting > 5 minutes.

Exclusion Criteria:

  1. Subject with an indication for the index procedure of acute ST-segment elevation MI (STEMI).
  2. Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, P2Y12 inhibitors (clopidogrel/prasugrel/ticagrelor), everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
  3. Subject with implantation of another drug-eluting stent (other than XIENCE) within 12 months prior to index procedure.
  4. Subject has a known left ventricular ejection fraction (LVEF) <30%.
  5. Subject judged by physician as inappropriate for discontinuation from P2Y12 inhibitor use at 1 month, due to another condition requiring chronic P2Y12 inhibitor use.
  6. Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 1 month following index procedure.
  7. Subject with a current medical condition with a life expectancy of less than 12 months.
  8. Subject intends to participate in an investigational drug or device trial within 12 months following the index procedure. Transferring to the XIENCE 90 study will not be an exclusion criterion.
  9. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
  10. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
  11. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.

Angiographic Exclusion Criteria

  1. Target lesion is in a left main location.
  2. Target lesion is located within an arterial or saphenous vein graft.
  3. Target lesion is restenotic from a previous stent implantation.
  4. Target lesion is a chronic total occlusion (CTO, defined as lesion with TIMI flow 0 for at least 3 months).
  5. Target lesion is implanted with overlapping stents, whether planned or for bailout.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03815175


Locations
Show Show 111 study locations
Sponsors and Collaborators
Abbott Medical Devices
Investigators
Layout table for investigator information
Principal Investigator: Roxana Mehran, MD Mount Sinai Medical Center,New York, NY
  Study Documents (Full-Text)

Documents provided by Abbott Medical Devices:
Study Protocol  [PDF] December 4, 2018
Statistical Analysis Plan  [PDF] September 4, 2020

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03815175    
Other Study ID Numbers: ABT-CIP-10402
First Posted: January 24, 2019    Key Record Dates
Results First Posted: December 14, 2021
Last Update Posted: May 3, 2022
Last Verified: April 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Abbott Medical Devices:
High Bleeding Risk (HBR)
Dual antiplatelet therapy (DAPT)
Drug eluting stent (DES)
XIENCE
Percutaneous coronary intervention (PCI)
Coronary Artery Disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Ischemic Stroke
Hemorrhagic Stroke
Renal Insufficiency
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Hemostatic Disorders
Thrombocytopenia
Blood Coagulation Disorders
Hematologic Diseases
Disease
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Blood Platelet Disorders
Kidney Diseases
Urologic Diseases
Hemorrhagic Disorders
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics