A Multicenter Observational Registry to Evaluate Safety and Performance of Vivo ISAR (SECURE Global Registry)

Mortality

• Any death due to proximate cardiac cause (e.g., myocardial infarction, low-output failure, fatal arrhythmia).
• Unwitnessed death and death of unknown cause.
• All procedure-related deaths (including those related to concomitant treatment).

Myocardial Infarction (including periprocedural myocardial infarction) as defined per the Fourth Universal Definition of Myocardial Infarction: "Detection of a rise and/or fall of cardiac troponin (cTn) with at least one value above the 99th percentile and with at least one of the following:

1. Symptoms of acute myocardial ischemia;
2. New ischemic electrocardiographic (ECG) changes;
3. Development of pathological Q waves;
4. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology;
5. Identification of a coronary thrombus by angiography including intracoronary imaging or by autopsy."

caused either by a clot obstructing the flow of blood to the brain (called an ischemic stroke) or by a blood vessel rupturing and preventing blood flow to the brain (called a hemorrhagic stroke)

Definite Stent Thrombosis:

Angiographic confirmation of stent thrombosis:

• The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent and presence of at least one of the following criteria within a 48-hour time window:
• Acute onset of ischemic symptoms at rest
• New ischemic ECG changes that suggest acute ischemia
• Typical rise and fall in cardiac biomarkers

1. Probable Stent Thrombosis Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:

• Any unexplained death within the first 30 days.
• Irrespective of the time after the index procedure, any MI that is related to documented ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

A TLR is considered ischemia-driven if angiography at follow-up shows a percent diameter stenosis ≥50% and if one of the following occurs:

• Positive history of recurrent angina pectoris, presumably related to the target vessel.
• Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel.
• Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve).
• A target lesion revascularisation (TLR) or target vessel revascularisation (TVR) with a diameter stenosis ≥70% even in the absence of the above-mentioned ischemic signs or symptoms TLR events which do not meet the criteria for ID-TLR are considered non-ID TLR events

Acute condition post index procedure where urgent revascularization of the target lesion is necessary

repeat percutaneous intervention or surgical bypass of any segment of a target vessel.

any overt, actionable sign of hemorrhage