Pharmacokinetics of Everolimus in Absorb BVS in Patients With Coronary Artery Lesions (NCT02229864) | Clinical Trial Compass
CompletedNot Applicable
Pharmacokinetics of Everolimus in Absorb BVS in Patients With Coronary Artery Lesions
United States12 participantsStarted 2014-05
Plain-language summary
The ABSORB III PK sub-study is a prospective, open-label, non-blinded study enrolling approximately 12 subjects in up to 5 US sites. ABSORB III PK sub-study is a part of ABSORB III RCT (NCT01751906). The objective is to determine the pharmacokinetics of everolimus delivered by the Absorb BVS in a separate and non-randomized cohort of subjects who only receive Absorb BVS with a maximum of two de novo native coronary artery lesions after implantation of the Absorb BVS.
Note: The ABSORB III PK subjects will not contribute to the determination of the ABSORB III RCT primary endpoint.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
β. 18 years of age.
β. Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.
β. Evidence of myocardial. In the absence of noninvasive ischemia, FFR must be done and indicative of ischemia.
β. An acceptable candidate for coronary artery bypass graft (CABG) surgery.
β. Female subject of childbearing potential who does not plan pregnancy for up to 1 year following the index procedure.
β. Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 1 year following the index procedure.
β. Subject agrees to not participate in any other investigational or invasive clinical study for a period of 1 year following the index procedure.
β. One or two de novo target lesions:
Exclusion criteria
β. Any surgery requiring general anesthesia or discontinuation of aspirin and/or an Adenosine diphosphate receptor (ADP) antagonist is planned within 12 months after the procedure.
β. Subject has known hypersensitivity or contraindication to device material and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated. Subject has a known contrast sensitivity that cannot be adequately pre-medicated.
β. Subject has known allergic reaction, hypersensitivity or contraindication to aspirin; or to clopidogrel and prasugrel and ticagrelor; or to heparin and bivalirudin, and therefore cannot be adequately treated with study medications.
β. Subject had an acute myocardial infarction (AMI: STEMI or NSTEMI) within 72 hours of the index procedure and both creatine kinase (CK) and creatine kinase myocardial-band isoenzyme (CK-MB) have not returned to within normal limits at the time of index procedure; or subject with stable angina or silent ischemia has CK-MB that is greater than normal limits at the time of the index procedure.
β. Subject is currently experiencing clinical symptoms consistent with new onset AMI (STEMI or NSTEMI), such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.
β. Subject has a cardiac arrhythmia as identified at the time of screening for which at least one of the following criteria is met:
β. Subject requires coumadin or any other agent for chronic oral anticoagulation
β. Subject is likely to become hemodynamically unstable due to their arrhythmia