OPtical Coherence Tomography (OCT) Guided Coronary Stent IMplantation Compared to Angiography: a Multicenter Randomized TriaL in PCI

Coe Jessie0 sites3,656 target enrollmentAugust 7, 2020

Overview

No summary available.

Registry

who.int

Start Date

August 7, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Coe Jessie

•1\. Subject must be at least 18 years of age.
•2\. Subject must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia (ischemia in the absence of chest pain or other anginal equivalents), unstable angina, or acute myocardial infarction) suitable for elective PCI.
•3\. Patients undergoing planned XIENCE stent implantation during a clinically indicated PCI procedure meeting one or more of the following criteria:
•A) High clinical\-risk, defined as;
•i.Medication\-treated diabetes mellitus, AND/OR
•B) High angiographic\-risk lesion(s), with at least one target lesion in each target vessel planned for randomization meeting at least one of the following criteria;
•i.Target lesion is the culprit lesion responsible for either:
•\-NSTEMI, defined as a clinical syndrome consistent with an acute coronary syndrome and a minimum troponin of 1 ng/dL (may or may not have returned to normal), OR
•\-STEMI \>24 hours from the onset of ischemic symptoms
•ii.long or multiple lesions (defined as intended total stent length in any single target vessel \>\=28 mm),

•1\. STEMI \<\=24 hours from the onset of ischemic symptoms
•2\. Creatinine clearance \<\=30 ml/min/1\.73 m2 (as calculated by MDRD formula for estimated GFR) and not on dialysis.
•3\. Hypotension, shock or need for mechanical support or intravenous vasopressors at the time the patient would be undergoing the index procedure.
•4\. CHF (Killip class \>\=2 or NYHA class \>\=3\)
•5\. LVEF \<\=30% by the most recent imaging test within 3 months prior to procedure. If no LVEF test result within 3 months is available, it must be assessed by echocardiography, multiple gated acquisition (MUGA), magnetic resonance imaging (MRI), ventriculography (LV gram) or other method.
•6\. Unstable ventricular arrhythmias
•7\. Inability to take DAPT (both aspirin and a P2Y12 inhibitor) for at least 12 months in the patient presenting with an ACS, or at least 6 months in the patient presenting with stable CAD, unless the patient is also taking chronic oral anticoagulation in which case a shorter duration of DAPT may be prescribed per local standard of care.
•8\. Planned major cardiac or non\-cardiac surgery within 24 months after the index procedure
•9\. Prior PCI within the target vessel within 12 months
•10\. Any planned PCI within the target vessel(s) within 24 months after the study procedure, other than a planned staged intervention in a second randomized target vessel.