coronary arteriosclerosis Obstructive coronary artery disease
Conditions
Interventions
Patients will be randomized to implantation of a drug-eluted stent (Xience
Prime) or BRS (Absorb).
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 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. *************
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MBF measurements: resting MBF, during endothelial dependent vasodilation provoked by cold-pressor-testing (CPT), and during (endothelial dependent and independent) maximal vasodilation by infusion of adenosine intravenously | — |
Secondary
| Measure | Time frame |
|---|---|
| Obstructive coronary lesions on control invasive coronary angiogram that may affect the MBF measurements. | — |
Countries
Netherlands
Outcome results
None listed