Table 5.

Safety of the JenaMACS trial. Any of the mentioned adverse events (AE) is considered as a serious adverse event (SAE) if it is directly caused, may have caused in the past or may cause in the future death or a serious aggravation of the state of health of a patient, user or another person if the incident was caused by the medical device. The events will be recorded from the moment the medical device is unpacked and inserted into the patient until follow-up at discharge.

Safety of the Trial

-Peri-procedural complications within 7 days combined from: pericardial effusion, stroke, major bleeding, embolization, intracranial bleeding. -Device related: thrombus, breakage, malfunction, allergic reactions. -Vascular access related complications requiring intervention/surgery. -Procedure related death. -Post-procedure infection rate. -Sepsis with clinical signs of infection and increased PCT (>2 pg/mL). -Peri-procedural outcomes at 7 and 30 days after implantation. -Bleeding requiring transfusion (BARC 2—5). -Severe and moderate bleeding complications (GUSTO definition). -Stroke. -Severe limb ischemia/peripheral vascular complications.

BARC = Bleeding academic research consortium, GUSTO = Global use of streptokinase and t-PA for occluded coronary arteries, PCT = procalcitonin.