Impact of Vascular Reparative Therapy on Vasomotor Function and Myocardial Perfusion: a randomized H215O PET/CT Study - VANISH

Vrije Universiteit Medisch Centrum0 个研究点目标入组 60 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

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•- Patients with documented obstructive CAD by invasive coronary angiography resulting in myocardial ischemia (either documented by invasive (i.e. fractional flow reserve, FFR) or noninvasive imaging techniques (e.g. exercise ECG, myocardial perfusion imaging, or inducibility of wall motion abnormalities during dobutamine stress).
•- Presence of a single, de-novo lesion in a native coronary artery (type A or B1), with a reference vessel diameter of at least 3.0 mm and a diameter stenosis of 50% or more and less than 100%, with a thrombolysis in myocardial infarction (TIMI) flow grade of at least 2. Coronary lesion must be amendable for successful treatment with one of the following BRS device dimensions: length 18 or 28 mm, diameter 3.0 or 3.5 mm.
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•- refusal or inability to provide written informed consent
•- other than single CAD
•- abnormal echocardiographic findings (i.e. wall motion abnormalities, ventricular hypertrophy, valvular disease etc.)
•- complex coronary lesion characteristics (e.g. lesions located in the left main coronary artery, lesions involving a side branch more than 2 mm in diameter, and the presence of thrombus or another clinically significant stenosis in the target vessel)
•- poor kidney function defined as an eGFR < 30 ml/min
•- astma or chronic obstructive pulmonary disease
•- other than sinus rhythm
•- pregnancy
•- bail out stenting after placement of the study device

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