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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 : Active, not recruiting
First Posted : January 24, 2019
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE January 22, 2019
First Posted Date  ICMJE January 24, 2019
Last Update Posted Date February 19, 2020
Actual Study Start Date  ICMJE February 25, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2019)
  • Composite rate of all death or all myocardial infarction (modified Academic Research Consortium [ARC]) [ Time Frame: From 1 to 6 months ]
  • Composite rate of all death or all myocardial infarction (modified ARC) [ Time Frame: From 6 to 12 months ]
  • Composite rate of all death or all myocardial infarction (modified ARC) [ Time Frame: From 1 to 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2019)
  • Number of participants with major bleeding rate (Bleeding Academic Research Consortium [BARC] type 2-5) [ Time Frame: From 1 to 6 months ]
    The major secondary endpoint is major bleeding rate (BARC type 2-5) from 1 to 6 months. Major secondary analysis will be performed only if the primary hypothesis testing is successful.
  • Number of participants with major bleeding rate (BARC type 2-5) [ Time Frame: From 6 to 12 months ]
  • Number of participants with major bleeding rate (BARC type 2-5) [ Time Frame: From 1 to 12 months ]
  • Number of participants with stent thrombosis (ARC definite/probable, ARC definite) [ Time Frame: From 1 to 6 months ]
  • Number of participants with stent thrombosis (ARC definite/probable, ARC definite) [ Time Frame: From 6 to 12 months ]
  • Number of participants with stent thrombosis (ARC definite/probable, ARC definite) [ Time Frame: From 1 to 12 months ]
  • Number of all death, cardiac death, vascular death, non-cardiovascular death [ Time Frame: From 1 to 6 months ]
  • Number of all death, cardiac death, vascular death, non-cardiovascular death [ Time Frame: From 6 to 12 months ]
  • Number of all death, cardiac death, vascular death, non-cardiovascular death [ Time Frame: From 1 to 12 months ]
  • 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 ]
  • Number of participants with all MI and MI attributed to target vessel (TV-MI, modified ARC) [ Time Frame: From 6 to 12 months ]
  • Number of participants with all MI and MI attributed to target vessel (TV-MI, modified ARC) [ Time Frame: From 1 to 12 months ]
  • Composite of cardiac death or MI (modified ARC) [ Time Frame: From 1 to 6 months ]
  • Composite of cardiac death or MI (modified ARC) [ Time Frame: From 6 to 12 months ]
  • Composite of cardiac death or MI (modified ARC) [ Time Frame: From 1 to 12 months ]
  • Composite of all death or all MI (modified ARC) [ Time Frame: From 1 to 6 months ]
  • Composite of all death or all MI (modified ARC) [ Time Frame: From 6 to 12 months ]
  • Composite of all death or all MI (modified ARC) [ Time Frame: From 1 to 12 months ]
  • Number of participants with all stroke, ischemic stroke and hemorrhagic stroke [ Time Frame: From 1 to 6 months ]
  • Number of participants with all stroke, ischemic stroke and hemorrhagic stroke [ Time Frame: From 6 to 12 months ]
  • Number of participants with all stroke, ischemic stroke and hemorrhagic stroke [ Time Frame: From 1 to 12 months ]
  • Number of participants with clinically-indicated target lesion revascularization (CI-TLR) [ Time Frame: From 1 to 6 months ]
  • Number of participants with CI-TLR [ Time Frame: From 6 to 12 months ]
  • Number of participants with CI-TLR [ Time Frame: From 1 to 12 months ]
  • Number of participants with clinically-indicated target vessel revascularization (CI-TVR) [ Time Frame: From 1 to 6 months ]
  • Number of participants with CI-TVR [ Time Frame: From 6 to 12 months ]
  • Number of participants with CI-TVR [ Time Frame: From 1 to 12 months ]
  • Number of participants with target lesion failure (TLF, composite of cardiac death, TV-MI and CI-TLR) [ Time Frame: From 1 to 6 months ]
  • Number of participants with target lesion failure (TLF, composite of cardiac death, TV-MI and CI-TLR) [ Time Frame: From 6 to 12 months ]
  • Number of participants with target lesion failure (TLF, composite of cardiac death, TV-MI and CI-TLR) [ Time Frame: From 1 to 12 months ]
  • Number of participants with target vessel failure (TVF, composite of cardiac death, TV-MI and CI-TVR) [ Time Frame: From 1 to 6 months ]
  • Number of participants with target vessel failure (TVF, composite of cardiac death, TV-MI and CI-TVR) [ Time Frame: From 6 to 12 months ]
  • Number of participants with target vessel failure (TVF, composite of cardiac death, TV-MI and CI-TVR) [ Time Frame: From 1 to 12 months ]
  • Number of participants with major bleeding (BARC type 3-5) [ Time Frame: From 1 to 6 months ]
  • Major bleeding defined by the (BARC type 3-5) [ Time Frame: From 6 to 12 months ]
  • Major bleeding defined by the (BARC type 3-5) [ Time Frame: From 1 to 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE XIENCE 28 USA Study
Official Title  ICMJE XIENCE 28 USA Study
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bleeding Disorder
  • Ischemic Stroke
  • Hemorrhagic Stroke
  • Hematological Diseases
  • Thrombocytopenia
  • Coagulation Disorder
  • Anemia
  • Renal Insufficiency
  • Coronary Artery Disease
Intervention  ICMJE
  • Device: XIENCE
    Subjects who received XIENCE family stent systems will be included.
  • Drug: DAPT (aspirin and/or P2Y12 receptor inhibitor)
    "1-month clear" subjects 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
Study Arms  ICMJE Experimental: XIENCE
XIENCE + 1 month DAPT
Interventions:
  • Device: XIENCE
  • Drug: DAPT (aspirin and/or P2Y12 receptor inhibitor)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 17, 2020)
642
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2019)
800
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03815175
Other Study ID Numbers  ICMJE ABT-CIP-10271
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abbott Medical Devices
Study Sponsor  ICMJE Abbott Medical Devices
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Roxana Mehran, MD Mount Sinai Medical Center,New York, NY
PRS Account Abbott Medical Devices
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP