Optical Coherence Tomography of the Saphenous Vein Graft (NCT05129228) | Clinical Trial Compass
UnknownNot Applicable
Optical Coherence Tomography of the Saphenous Vein Graft
United States760 participantsStarted 2022-04-04
Plain-language summary
OCTOCAB is a prospective, randomized (1:1), single-center trial. The purpose of this study is to determine whether intravascular optical coherence tomography (OCT) guided saphenous vein grafting in coronary artery bypass surgery will reduce the rate of early vein graft failure (VGF).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject must be at least 18 years of age.
✓. 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 CABG.
✓. Subject must have undergone coronary angiography identifying at least one lesion that is clinically appropriate and suitable for saphenous vein bypass grafting.
✓. Subject must provide written Informed Consent prior to any study related procedure.
Exclusion criteria
✕. STEMI ≤24 hours from the onset of ischemic symptoms
✕. Creatinine clearance ≤30 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR) and not on dialysis.
✕. Hypotension, shock or need for mechanical support or intravenous vasopressors at the time that the patient would be undergoing the index procedure.
✕. CHF (Killip class \>2 or NYHA class \>3)
✕. LVEF \<30% by the most recent imaging test within 6 months prior to procedure. If no LVEF test result within 6 months is available, it must be assessed by echocardiography, multiple gated acquisition (MUGA), magnetic resonance imaging (MRI), ventriculography (LV gram) or other method.
✕. Unstable ventricular arrhythmias
✕. Concomitant multi-valve surgery or major aortic root surgery.