First-In-Human Trial of the MiStent Drug-Eluting Stent (DES) in Coronary Artery Disease

Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q-wave and non-Q-wave) and target vessel revascularization (TVR)

Achievement of a final in-stent residual diameter stenosis of <50% (by QCA), using the assigned device only

Achievement of a final in-stent residual diameter stenosis of <50% (by QCA) using any percutaneous method

Achievement of a final in-stent residual diameter stenosis of <50% (by QCA) using the assigned device (including any adjunctive devices) without cardiac death, Myocardial infarction (MI) or repeat revascularization of the target lesion pre-hospital discharge

Total mortality (cardiac and non-cardiac)

1. Q-wave MI (QWMI): requires one of the following criteria: the development of new abnormal Q waves in ≥2 contiguous ECG leads not present on the patient's baseline (i.e., before intervention) in association with a >2x upper limit normal elevation of creatine kinase (CK) levels. In the absence of ECG data, the clinical events committee may adjudicate a Q-wave MI based on the clinical scenario and appropriate cardiac enzyme data; chest pain or other acute symptoms consistent with myocardial ischemia and new pathological Q waves in ≥2 contiguous ECG leads in the absence of timely cardiac enzyme data.
2. Non-Q-wave MI (NQWMI): the elevation of CK levels (≥2 times ULN) with elevated CK-MB enzyme levels in the absence of new pathologic Q waves.

A revascularization is considered clinically driven if angiography at follow-up shows a percent diameter stenosis ≥ 50% (Angiographic Core Laboratory QCA assessment) and if one of the following occurs:

1. A positive history of recurrent angina pectoris, presumably related to the target vessel;
2. Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
3. Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve);
4. A target lesion revascularization (TLR) with a diameter stenosis ≥ 70% even in the absence of the above-mentioned ischemic signs or symptoms.

A revascularization is considered clinically driven if angiography at follow-up shows a percent diameter stenosis ≥ 50% (Angiographic Core Laboratory QCA assessment) and if one of the following occurs:

1. A positive history of recurrent angina pectoris, presumably related to the target vessel;
2. Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
3. Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve);
4. A target vessel revascularization (TVR) with a diameter stenosis ≥ 70% even in the absence of the above-mentioned ischemic signs or symptoms.

Target vessel failure (TVF) is defined as the composite endpoint of:

• cardiac death,
• target-vessel myocardial infarction (Q wave or non-Q wave), and
• clinically indicated target vessel revascularization

Target lesion failure (TLF) is defined as the composite endpoint of:

• cardiac death,
• target-lesion myocardial infarction (Q wave or non-Q wave), and
• clinically indicated target lesion revascularization

The presence of an intracoronary thrombus that originates in the stent or in the segments 5 mm proximal or distal to the stent post-procedure

Binary Restenosis is defined as ≥50% luminal narrowing at follow-up angiography.

Binary Restenosis is defined as ≥50% luminal narrowing at follow-up angiography.

% neointimal volume obstruction is defined as the neointimal volume divided by stent volume.

% neointimal volume obstruction is defined as the neointimal volume divided by stent volume.

% stent strut uncovered is defined as the ratio of uncovered struts to total struts in all cross-sections.

% stent strut uncovered is defined as the ratio of uncovered struts to total struts in all cross-sections.