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XIENCE 28 Global 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: NCT03355742
Recruitment Status : Completed
First Posted : November 28, 2017
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE November 22, 2017
First Posted Date  ICMJE November 28, 2017
Last Update Posted Date May 6, 2020
Actual Study Start Date  ICMJE February 9, 2018
Actual Primary Completion Date October 24, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2017)
Net Adverse Clinical Endpoint (NACE): Composite Rate of all-cause death and all myocardial infarction (MI), stent thrombosis, stroke or major bleeding (Bleeding defined by the Bleeding Academic Research Consortium [BARC] type 2-5) [ Time Frame: From 1 to 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2017)
  • Net Adverse Clinical Endpoint (NACE): Composite Rate of all-cause death and all myocardial infarction (MI), stent thrombosis, stroke or major bleeding (BARC type 2-5) [ Time Frame: From 1 to 12 months ]
  • Net Adverse Clinical Endpoint (NACE): Composite Rate of all-cause death and all myocardial infarction (MI), stent thrombosis, stroke or major bleeding (BARC type 2-5) [ Time Frame: From 6 to 12 months ]
  • Stent thrombosis (ARC definite/probable, ARC definite) [ Time Frame: From 1 to 6 months ]
  • Stent thrombosis (ARC definite/probable, ARC definite) [ Time Frame: From 6 to 12 months ]
  • Stent thrombosis (ARC definite/probable, ARC definite) [ Time Frame: From 1 to 12 months ]
  • All Deaths, Cardiac Death, Vascular Death, and Non-cardiovascular death [ Time Frame: From 1 to 6 months ]
  • All Deaths, Cardiac Death, Vascular Death, and Non-cardiovascular death [ Time Frame: From 6 to 12 months ]
  • All Deaths, Cardiac Death, Vascular Death, and Non-cardiovascular death [ Time Frame: From 1 to 12 months ]
  • All MI and MI Attributed to Target Vessel (TV-MI) [ Time Frame: From 1 to 6 months ]
  • All MI and MI Attributed to Target Vessel (TV-MI) [ Time Frame: From 6 to 12 months ]
  • All MI and MI Attributed to Target Vessel (TV-MI) [ Time Frame: From 1 to 12 months ]
  • Composite of Cardiac death or MI [ Time Frame: From 1 to 6 months ]
  • Composite of Cardiac death or MI [ Time Frame: From 6 to 12 months ]
  • Composite of Cardiac death or MI [ Time Frame: From 1 to 12 months ]
  • Composite of all death or all MI [ Time Frame: From 1 to 6 months ]
  • Composite of all death or all MI [ Time Frame: From 6 to 12 months ]
  • Composite of all death or all MI [ Time Frame: From 1 to 12 months ]
  • All stroke, Ischemic stroke and Hemorrhagic stroke [ Time Frame: From 1 to 6 months ]
  • All stroke, Ischemic stroke and Hemorrhagic stroke [ Time Frame: From 6 to 12 months ]
  • All stroke, Ischemic stroke and Hemorrhagic stroke [ Time Frame: From 1 to 12 months ]
  • Clinically-indicated target lesion revascularization (CI-TLR) [ Time Frame: From 1 to 6 months ]
  • Clinically-indicated target lesion revascularization (CI-TLR) [ Time Frame: From 6 to 12 months ]
  • Clinically-indicated target lesion revascularization (CI-TLR) [ Time Frame: From 1 to 12 months ]
  • Clinically-indicated target vessel revascularization (CI-TVR) [ Time Frame: From 1 to 6 months ]
  • Clinically-indicated target vessel revascularization (CI-TVR) [ Time Frame: From 6 to 12 months ]
  • Clinically-indicated target vessel revascularization (CI-TVR) [ Time Frame: From 1 to 12 months ]
  • Target lesion failure (TLF, composite of Cardiac death, TV-MI and CI-TLR) [ Time Frame: From 1 to 6 months ]
  • Target lesion failure (TLF, composite of Cardiac death, TV-MI and CI-TLR) [ Time Frame: From 6 to 12 months ]
  • Target lesion failure (TLF, composite of Cardiac death, TV-MI and CI-TLR) [ Time Frame: From 1 to 12 months ]
  • Target vessel failure (TVF, composite of Cardiac death, TV-MI and CI-TVR) [ Time Frame: From 1 to 6 months ]
  • Target vessel failure (TVF, composite of Cardiac death, TV-MI and CI-TVR) [ Time Frame: From 6 to 12 months ]
  • Target vessel failure (TVF, composite of Cardiac death, TV-MI and CI-TVR) [ Time Frame: From 1 to 12 months ]
  • Bleeding defined by the BARC type 2-5 and type 3-5 [ Time Frame: From 1 to 6 months ]
  • Bleeding defined by the BARC type 2-5 and type 3-5 [ Time Frame: From 6 to 12 months ]
  • Bleeding defined by the BARC type 2-5 and 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 Global Study
Official Title  ICMJE XIENCE 28 Global Study
Brief Summary XIENCE 28 Global Study is a prospective, single arm, multi-center, open label, non-randomized trial to further evaluate the 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, XIENCE PROX EECSS, XIENCE ProA EECSS or XIENCE Sierra EECSS of coronary drug-eluting stents
Detailed Description

The XIENCE 28 Global Study will evaluate the safety of 1-month DAPT following XIENCE implantation in HBR patients. A minimum of 800 to a maximum of 960 subjects will be registered from approximately 50 sites globally and subject registration is capped at 120 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 continue 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 Global Study will be compared with the historical control of non-complex HBR subjects treated with standard DAPT 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
  • Stroke, Ischemic
  • Stroke Hemorrhagic
  • Hematological Disease
  • 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
    1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
    Other Name: Dual antiplatelet therapy
Study Arms  ICMJE Experimental: XIENCE
XIENCE + Short duration (1 month) of DAPT
Interventions:
  • Device: XIENCE
  • Drug: DAPT
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 Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2019)
960
Original Estimated Enrollment  ICMJE
 (submitted: November 22, 2017)
800
Actual Study Completion Date  ICMJE April 30, 2020
Actual Primary Completion Date October 24, 2019   (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. Subjects ≥ 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/mm^3, 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 Ethics Committee (EC) 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.

Angiographic Inclusion Criteria

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

    1. 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.
    2. 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 thrombolysis in myocardial infarction (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.
  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.

    Note: Female subjects of childbearing potential should be instructed to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release.) It is accepted, in certain cases, to include subjects having a sterilised regular partner or subjects using a double barrier contraceptive method. However, this should be explicitly justified in special circumstances arising from the trial design, product characteristics and/or trial population

  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.

Note: If there is more than one target lesion, all target lesions must satisfy the angiographic eligibility criteria. Non-target lesion (i.e., lesions that do not meet the angiographic criteria listed above) treatments are not allowed during the index procedure.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Austria,   Belgium,   China,   Germany,   Hong Kong,   Italy,   Netherlands,   Portugal,   Singapore,   Spain,   Switzerland,   Taiwan,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03355742
Other Study ID Numbers  ICMJE ABT-CIP-10235
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: No
Product Manufactured in and Exported from the U.S.: No
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: Marco Valgimigli, MD Bern University Hospital
PRS Account Abbott Medical Devices
Verification Date May 2020

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