XIENCE 90: A Safety Evaluation of 3-month DAPT After XIENCE Implantation for HBR Patients.

Completed · Not applicable

Conditions studied: Coronary Artery Lesions

In brief

XIENCE 90 study is a prospective, single arm, multi-center, open label trial to evaluate the safety of 3-month dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary intervention (PCI) with the approved XIENCE family of coronary drug-eluting stents. The XIENCE family stent systems include commercially approved XIENCE Xpedition Everolimus Eluting Coronary Stent System (EECSS), XIENCE Alpine EECSS, XIENCE PRO\^X EECSS \[rebrand of the XIENCE Xpedition Stent System and is only available outside of the United States (OUS)\], XIENCE PRO\^A EECSS (rebrand of the XIENCE Alpine Stent System and is only available OUS) and XIENCE Sierra EECSS of coronary drug-eluting stents.

Key facts

Study ID

NCT03218787

Run by

Abbott Medical Devices

People needed

2047

Starts

2017-07-19

Expected to finish

2020-09-04

Last updated by the study team

2021-11-05

Who can join

Age: 18 and older. 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 > 3-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/mm\^3, 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 or a legally authorized representative must provide written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site prior to any study related procedure.
• Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at 3 months, 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.
• 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 patient 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 ≤ 32 mm in length by visual estimation.
• 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 > 0.5 mm or depression lasting > 5 minutes.
• General Exclusion Criteria
• 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 9 months prior to index procedure.
• Subject has a known left ventricular ejection fraction (LVEF) <30%.

Where it is running

• Scottsdale Healthcare Hospitals (d/b/a HonorHealth - HonorHealth Research Institute) — Scottsdale, Arizona, United States
• Arkansas Heart Hospital — Little Rock, Arkansas, United States
• John Muir Health Concord — Concord, California, United States
• Washington Hospital (Mission Cardiovascular Research Institute) — Fremont, California, United States
• Scripps Memorial Hospital/Prebys Cardiovascular Institute — La Jolla, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• Sharp Grossmont Hospital (La Mesa Cardiac Center) — San Diego, California, United States
• Sharp Memorial Hospital / San Diego Cardiac Center — San Diego, California, United States
• Santa Barbara Cottage Hospital/Sansum Clinic — Santa Barbara, California, United States
• Torrance Memorial Medical Center — Torrance, California, United States
• Rocky Mountain Regional VA Medical Center — Aurora, Colorado, United States
• Medstar Washington Hospital — Washington D.C., District of Columbia, United States
• JFK Medical Center — Atlantis, Florida, United States
• Clearwater Cardiovasular Consultants — Clearwater, Florida, United States
• Morton Plant Mease Healthcare System — Clearwater, Florida, United States
• North Florida Regional / The Cardiac and Vascular Institute — Gainesville, Florida, United States
• St. Vincent's Medical Center (St. Vincent's Healthcare) — Jacksonville, Florida, United States
• Tallahassee Memorial Hospital / Tallahassee Research Institute, Inc. — Tallahassee, Florida, United States
• University Health, INC/University Cardiology Associates, LLC — Augusta, Georgia, United States
• Augusta Medical Center — Augusta, Georgia, United States
• Atlanta Veterans Affairs Medical Center — Decatur, Georgia, United States
• North Georgia Heart Foundation, Inc. — Gainesville, Georgia, United States
• St. John's Hospital — Springfield, Illinois, United States
• Huntsville Hospital (Heart Center Research LLC) — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.