XIENCE 28 USA Study

Completed · Not applicable

Conditions studied: Bleeding Disorder, Ischemic Stroke, Hemorrhagic Stroke, Hematological Diseases, Thrombocytopenia, Coagulation Disorder, Anemia, Renal Insufficiency, Coronary Artery Disease

In brief

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.

Key facts

Study ID: NCT03815175
Run by: Abbott Medical Devices
People needed: 1605
Starts: 2019-02-25
Expected to finish: 2021-02-04
Last updated by the study team: 2022-05-03

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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:
≥ 75 years of age.
Clinical indication for chronic (at least 6 months) or lifelong anticoagulation therapy
History of major bleeding which required medical attention within 12 months of the index procedure.
History of stroke (ischemic or hemorrhagic).
Renal insufficiency (creatinine ≥ 2.0 mg/dl) or failure (dialysis dependent).
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).
Anemia with hemoglobin < 11g/dl.
Subject must be at least 18 years of age.
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.
Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at 1 month, if eligible per protocol.
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
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.
Target lesion must be located in a native coronary artery with visually estimated reference vessel diameter between 2.25 mm and 4.25 mm.
Exclusive use of XIENCE family of stent systems during the index procedure.
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.

You may not qualify if…

Subject with an indication for the index procedure of acute ST-segment elevation MI (STEMI).
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.
Subject with implantation of another drug-eluting stent (other than XIENCE) within 12 months prior to index procedure.
Subject has a known left ventricular ejection fraction (LVEF) <30%.
Subject judged by physician as inappropriate for discontinuation from P2Y12 inhibitor use at 1 month, due to another condition requiring chronic P2Y12 inhibitor use.
Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 1 month following index procedure.
Subject with a current medical condition with a life expectancy of less than 12 months.
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.
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.
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.
Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
Angiographic Exclusion Criteria
Target lesion is in a left main location.
Target lesion is located within an arterial or saphenous vein graft.
Target lesion is restenotic from a previous stent implantation.
Target lesion is a chronic total occlusion (CTO, defined as lesion with TIMI flow 0 for at least 3 months).
Target lesion is implanted with overlapping stents, whether planned or for bailout.

Where it is running

Phoenix Cardiovascular Research Group — Phoenix, Arizona, United States
Scottsdale Healthcare Shea — Scottsdale, Arizona, United States
NEA Baptist Clinic — Jonesboro, Arkansas, United States
Arkansas Heart Hospital — Little Rock, Arkansas, United States
Mission Cardiovascular Research Institute — Fremont, California, United States
Scripps Memorial Hospital - La Jolla — La Jolla, California, United States
Huntington Memorial Hospital — Pasadena, California, United States
Santa Barbara Cottage Hospital — Santa Barbara, California, United States
Kaiser Permanente - Santa Clara — Santa Clara, California, United States
Cardiology Associates of Fairfield County, PC — Norwalk, Connecticut, United States
Washington Hospital Center — Washington D.C., District of Columbia, United States
Clearwater Cardiovascular Consultants — Clearwater, Florida, United States
Morton Plant Hospital — Clearwater, Florida, United States
Tallahassee Research Institute — Tallahassee, Florida, United States
Northeast Georgia Medical Center — Gainesville, Georgia, United States
Redmond Regional Medical Center — Rome, Georgia, United States
Via Christi Regional Medical Center - St. Francis Campus — Wichita, Kansas, United States
Cardiovascular Research Institute of Kansas — Wichita, Kansas, United States
Eastern Maine Medical Center — Bangor, Maine, United States
Union Memorial Hospital — Baltimore, Maryland, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Beth Isreal Deaconess Medical Center — Boston, Massachusetts, United States
McLaren Health Care Corporation — Auburn Hills, Michigan, United States
Munson Medical Center — Traverse City, Michigan, United States
Heart Center Research, LLC — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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