The purpose of this study is to determine the optimal way of predilatation for BVS implantation.
Randomized, single-center study. Forty-five patients with intended BVS implantation will be randomized in ratio of 1:1:1 to different predilatation strategies(non-compliant balloon/Emerge NC™, Boston Scientific, cutting balloon/Flexitome™, scoring balloon/Scoroflex™,Orbus). Predilatation is intended to be done in a vessel:balloon ratio of 1:1. If the device is not able enter the lesion, it will be replaced with a conventional semicompliant balloon with the same predilatation strategy (a vessel:balloon ratio of 1:1) After a successful predilatation, the BVS (Absorb™, Abbott) will be implanted and this procedure will be accomplished by a high pressure postdilatation with a non-compliant balloon (Emerge NC™, BSCI). The MLA of the Absorb stent will be evaluated with optical coherence tomography (OPTIS, St.Jude).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Coronary artery stenosis is dilated before BVS implantation with the use of non-compliant balloon (standard procedure). Size and dilatation pressure is done according to OCT measurement of the coronary artery (distal segment / balloon diameter = 1:1)
Coronary artery stenosis is dilated before BVS implantation with the use of scoring balloon. Size and dilatation pressure is done according to OCT measurement of the coronary artery (distal segment / balloon diameter = 1:1)
Coronary artery stenosis is dilated before BVS implantation with the use of cutting balloon. Size and dilatation pressure is done according to OCT measurement of the coronary artery (distal segment / balloon diameter = 1:1)
Minimal lumen area (MLA) in the BVS (mm2)
After BVS implantation, optical coherence tomography is used to measure MLA in the scaffold area.
Time frame: Immediately after BVS implantation
Clinically - driven target vessel revascularization
Patient is followed after BVS implantation in 1,6 and 12 months in the outpatient department.
Time frame: 12 months after the procedure
Eccentricity index
After BVS implantation, optical coherence tomography is used to measure MLA in the scaffold area. Eccentricity index is calculated as minimal luminal diameter divided by maximal luminal diameter in the MLA segment.
Time frame: Immediately after BVS implantation
Expansion index
After BVS implantation, optical coherence tomography is used to measure MLA in the scaffold area. Expansion index is calculated as minimal luminal diameter divided by maximal expected diameter of the non-compliant balloon used for high pressure postdilatation.
Time frame: Immediately after BVS implantation
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