XIENCE 28 USA Study

• 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: Abbott Medical Devices
• Information provided by (Responsible Party): Abbott Medical Devices

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, Alabama

Heart Center Research, LLC

Huntsville, Alabama, United States, 35801

United States, Arizona

Phoenix Cardiovascular Research Group

Phoenix, Arizona, United States, 85018

Scottsdale Healthcare Shea

Scottsdale, Arizona, United States, 85260

United States, Arkansas

NEA Baptist Clinic

Jonesboro, Arkansas, United States, 72401

Arkansas Heart Hospital

Little Rock, Arkansas, United States, 72211

United States, California

Mission Cardiovascular Research Institute

Fremont, California, United States, 94538

Scripps Memorial Hospital - La Jolla

La Jolla, California, United States, 92037

Huntington Memorial Hospital

Pasadena, California, United States, 91109

Santa Barbara Cottage Hospital

Santa Barbara, California, United States, 93105

Kaiser Permanente - Santa Clara

Santa Clara, California, United States, 95051

United States, Connecticut

Cardiology Associates of Fairfield County, PC

Norwalk, Connecticut, United States, 06851

United States, District of Columbia

Washington Hospital Center

Washington, District of Columbia, United States, 20010

United States, Florida

Clearwater Cardiovascular Consultants

Clearwater, Florida, United States, 33756

Morton Plant Hospital

Clearwater, Florida, United States, 33756

Tallahassee Research Institute

Tallahassee, Florida, United States, 32308

United States, Georgia

Northeast Georgia Medical Center

Gainesville, Georgia, United States, 30501

Redmond Regional Medical Center

Rome, Georgia, United States, 30165

United States, Kansas

Via Christi Regional Medical Center - St. Francis Campus

Wichita, Kansas, United States, 67214-3882

Cardiovascular Research Institute of Kansas

Wichita, Kansas, United States, 67226

United States, Maine

Eastern Maine Medical Center

Bangor, Maine, United States, 04401

United States, Maryland

Union Memorial Hospital

Baltimore, Maryland, United States, 21218

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Beth Isreal Deaconess Medical Center

Boston, Massachusetts, United States, 02215

United States, Michigan

McLaren Health Care Corporation

Auburn Hills, Michigan, United States, 48326

Munson Medical Center

Traverse City, Michigan, United States, 49684

United States, Minnesota

Minneapolis Heart Institute

Minneapolis, Minnesota, United States, 55407

United States, Mississippi

Jackson Heart Clinic

Jackson, Mississippi, United States, 39216

United States, Missouri

Missouri Heart Center

Columbia, Missouri, United States, 65201

United States, New Jersey

Jersey Shore University Medical Center

Neptune, New Jersey, United States, 07753

United States, New York

Mount Sinai Hospital

New York, New York, United States, 10019

Lenox Hill Hospital

New York, New York, United States, 10021

St. Joseph's Hospital Health Center

Syracuse, New York, United States, 13203

United States, North Carolina

Novant Health Heart and Vascular Research Institute

Charlotte, North Carolina, United States, 28204

Cone Health Medical Group Heartcare

Greensboro, North Carolina, United States, 27401

NC Heart & Vascular Research

Raleigh, North Carolina, United States, 27607

Wake Forest University Medical Center Clinical Sciences

Winston-Salem, North Carolina, United States, 27157- 1045

United States, Ohio

Kettering Medical Center

Kettering, Ohio, United States, 45429

St. Vincent Mercy Medical Center

Toledo, Ohio, United States, 43608

United States, Pennsylvania

UPMC Hamot

Erie, Pennsylvania, United States, 16550

Pinnacle Health System

Harrisburg, Pennsylvania, United States, 17105

Presbyterian Medical Center (PA)

Philadelphia, Pennsylvania, United States, 19104

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States, 15212

St. Joseph Medical Center

Reading, Pennsylvania, United States, 19605

United States, South Carolina

Anmed Health

Anderson, South Carolina, United States, 29621

United States, South Dakota

Sanford USD Medical Center

Sioux Falls, South Dakota, United States, 57117

United States, Tennessee

East Tennessee Heart Consultants

Knoxville, Tennessee, United States, 37920

Centennial Medical Center

Nashville, Tennessee, United States, 37203

United States, Texas

Austin Heart

Austin, Texas, United States, 78756

Baylor Scott and White Heart and Vascular Hospital

Dallas, Texas, United States, 75226

Mission Research Institute

New Braunfels, Texas, United States, 78130

HeartPlace Methodist Richardson

Richardson, Texas, United States, 75082

East Texas Medical Center

Tyler, Texas, United States, 75701

United States, Virginia

Mary Washington Hospital

Fredericksburg, Virginia, United States, 22401

United States, West Virginia

Charleston Area Medical Center

Charleston, West Virginia, United States, 25304

Austria

Kepler Universitätsklinikum GmbH

Linz, Upr Aus, Austria, 4021

Belgium

Onze-Lieve-Vrouwziekenhuis Campus Aalst

Aalst, Eflndrs, Belgium, 9300

UZ Gent

Gent, Flemish, Belgium, 42100

Ziekenhuis Oost-Limburg

Genk, Limburg, Belgium, 3600

Jesse Ziekenhuis Campus Virga Jesse

Limbourg, Belgium, 3500

Canada, Alberta

Foothills Medical Centre

Calgary, Alberta, Canada, T2N 2T9

Canada, British Columbia

Royal Jubilee Hospital

Victoria, British Columbia, Canada, V8R 1J8

Canada, New Brunswick

Saint John Regional Hospital - New Brunswick Heart Centre

Saint John, New Brunswick, Canada, E2L4L2

Canada, Quebec

Institute de Cardiologie de Montreal (Montreal Heart Inst.)

Montréal, Quebec, Canada, H1T1C8

Hopital du Sacre-Coeur de

Montréal, Quebec, Canada, H4J1C5

China, Beijing

Beijing AnZhen Hospital

Beijing, Beijing, China, 100029

China, N China

The Second Hospital of Jilin University

Changchun, N China, China, 130041

Germany

Universitäts-Herzzentrum Freiburg - Bad Krozingen

Bad Krozingen, Bad-Wur, Germany, 79189

Elisabeth-Krankenhaus Essen GmbH

Essen, N. Rhin, Germany, 45138

UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität MainzLangenbeckstrasse

Mainz, Rhinela, Germany, 55131

Herzzentrum Leipzig GmbH04289

Leipzig, Saxony, Germany, 04289

Segeberger Kliniken GmbH Am Kurpark 1

Bad Segeberg, Schlesw, Germany, 23795

Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)

Berlin, Germany, 12200

UKE Hamburg (Universitatsklinik Eppendorf)

Hamburg, Germany, 20246

Hong Kong

The University of Hong Kong (Queen Mary Hospital)

Hong Kong, Hong Kong, 1928

Prince of Wales Hospital

Hong Kong, Hong Kong

Queen Elizabeth Hospital

Hong Kong, Hong Kong

Italy

Clinica Mediterranea

Napoli, Campani, Italy, 80122

AOU Federico II - Università degli Studi di Napoli

Napoli, Campani, Italy, 80138

Az.Osp. Universitaria di Ferrara

Cona, Emi-rom, Italy, 44124

AOU di Parma

Parma, Emi-rom, Italy, 43126

Policlinico Universitario A. Gemelli

Roma, Latium, Italy, 00168

Azienda Ospedaliero Universitaria Policlinico Umberto I

Rome, Latium, Italy, 00161

Centro Cardiologico Monzino

Milano, Lombard, Italy, 20138

Istituto Clinico Humanitas

Rozzano, Lombard, Italy, 20089

Netherlands

Scheperziekenhuis Boermarkeweg

Emmen, Drenthe, Netherlands, 7824

Medisch Centrum Leeuwarden

Leeuwarden, Friesld, Netherlands, 8934

Albert Schweitzer Ziekenhuis Albert Schweitzerplaats

Dordrecht, Zuid, Netherlands, 3318

Portugal

Hospital de Santa Cruz

Carnaxide, Lisbon, Portugal, 2799-523

Santa Maria Hospital

Lisboa, Lisbon, Portugal, 1649-035

Singapore

National Heart Centre

Singapore, Central Singapore, Singapore, 169609

Tan Tock Seng Hospital

Singapore, Singapore Central, Singapore, 308433

Spain

HCU Virgen de la Victoria Campus Universitario de Teatinos

Málaga, Andalu, Spain, 29010

Hospital Universitario Marqués de Valdecilla

Santander, Cantabr, Spain, 39008

Hospital del Mar Passeig Maritim de la Barceloneta

Barcelona, Catalon, Spain, 08003

Hospital Clinic I Provincial de Barcelona

Barcelona, Catalon, Spain, 08036

Hospital Clinico Universitario de Valladolid

Valladolid, Cstleon, Spain, 47005

Hospital Alvaro Cunqueiro

Vigo, Pontev, Spain, 36312

Hospital Universitario Doce de Octubre

Madrid, Spain, 28041

Switzerland

Kantonsspital Aarau

Aarau, Basel, Switzerland, 5001

Center Inselspital Bern

Bern, Switzerland, 3010

Luzerner Kantonsspital

Luzern, Switzerland, 6004

Taiwan

Chang Gung Memorial Hospital

Linkou, NTaiwan, Taiwan, 333

National Taiwan University Hospital

Taipei, NTaiwan, Taiwan, 10002

Taipei Veterans General Hospital (VGH)

Taipei, Ntaiwan, Taiwan, 11217

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung, STailwan, Taiwan, 83301

United Kingdom

Freeman Hospital

High Heaton, Newcastle Upon Tyne, United Kingdom, NE7 7DN

Craigavon Area Hospital

Portadown, Nirelnd, United Kingdom, BT63 5QQ

Southampton University Hospital

Southampton, Soeast, United Kingdom, SO16 6YD

Royal Bournemouth Hospital

Bournemouth, Sowest, United Kingdom, BH7 7DW

Royal Devon & Exeter Hospital

Exeter, Sowest, United Kingdom, EX2 5DW

University Hospital of Wales

Cardiff, Wales, United Kingdom, CF14 4XW

Sponsors and Collaborators

Abbott Medical Devices

Investigators

• 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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Valgimigli M, Cao D, Angiolillo DJ, Bangalore S, Bhatt DL, Ge J, Hermiller J, Makkar RR, Neumann FJ, Saito S, Picon H, Toelg R, Maksoud A, Chehab BM, Choi JW, Campo G, De la Torre Hernandez JM, Kunadian V, Sardella G, Thiele H, Varenne O, Vranckx P, Windecker S, Zhou Y, Krucoff MW, Ruster K, Zheng Y, Mehran R; XIENCE 90 and XIENCE 28 Investigators. Duration of Dual Antiplatelet Therapy for Patients at High Bleeding Risk Undergoing PCI. J Am Coll Cardiol. 2021 Nov 23;78(21):2060-2072. doi: 10.1016/j.jacc.2021.08.074.

Valgimigli M, Cao D, Makkar RR, Bangalore S, Bhatt DL, Angiolillo DJ, Saito S, Ge J, Neumann FJ, Hermiller J, Picon H, Toelg R, Maksoud A, Chehab BM, Wang LJ, Wang J, Mehran R. Design and rationale of the XIENCE short DAPT clinical program: An assessment of the safety of 3-month and 1-month DAPT in patients at high bleeding risk undergoing PCI with an everolimus-eluting stent. Am Heart J. 2021 Jan;231:147-156. doi: 10.1016/j.ahj.2020.09.019. Epub 2020 Oct 6.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT03815175
• Other Study ID Numbers: ABT-CIP-10402
• First Posted: January 24, 2019
• Results First Posted: December 14, 2021
• Last Update Posted: May 3, 2022
• Last Verified: April 2022

• 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:

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; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hemorrhagic Disorders