Study aim : To compare a novel strategy of lesion preparation with noncompliant balloons before implantation of BVS. Hypothesis: Predilatation with non-compliant balloons could facilitate optimal deployment of BVS. By achieving good scaffold apposition a need for post-dilatation could be significantly reduced. This is expected to result in better short- and long-term outcomes.
Study design: Following pre-dilatation a BVS will be implanted and optical coherence tomography (OCT) will be performed in all patients. After OCT post-dilatation with non-compliant balloons might be performed if this is considered necessary by the treating interventionist. Final OCT will be performed in all patients. 1:1 Randomization of two strategies before the implantation of bioresorbable scaffolds: * OPN strategy (study group): pre-dilatation with OPN® NC (non-compliant) Super High Pressure PTCA (percutaneous transluminal coronary angioplasty) balloons * standard strategy (control group): pre-dilatation with a standard (compliant) balloon Enrolment: Randomization of 50 patients * 25 in the OPN strategy (study group) * 25 in the standard strategy (control group)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Predilatation with OPN balloon will be performed as a lesion preparation for BVS Absorb implantation.
Predilatation with standard balloon will be performed as a lesion preparation for BVS Absorb implantation.
Luzerner Kantonsspital
Lucerne, Switzerland
Apposition of bioresorbable scaffold immediately after stent implantation following: pre-dilatation with OPN vs. pre-dilatation with standard balloons.
Stent apposition will be assessed based on OCT (optical coherence tomography) visualization.
Time frame: During the index procedure
Procedural success defined as successful delivery of the scaffold.
The frequency of procedural success will be compared in both study groups.
Time frame: During the index procedure
Need for post-dilatation after initial OCT.
The frequency of post-dilatation will be compared in both study groups.
Time frame: During the index procedure
Scaffold apposition after post-dilatation.
The scaffold apposition after post-dilatation will be compared based on OCT assessment in both study groups.
Time frame: During the index procedure
Periprocedural complications: dissection, slow- or no flow, dissection requiring additional stent implantation.
The frequency of periprocedural complications as dissection, slow-flow, no flow and dissection requiring additional stent implantation will be compared separately in both study group.
Time frame: During the index procedure
Periprocedural myocardial infarction defined as 5x upper reference level elevation of high sensitive Troponin I (in patients with normal pre-procedural Troponin).
The frequency of periprocedural myocardial infarction will be compared in both study groups.
Time frame: During the index procedure
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In-stent restenosis requiring revascularization within 12 months post-procedure.
The frequency of in-stent restenosis requiring revascularization will be compared in both study groups in 12 months follow-up.
Time frame: 12 months after the index procedure
Rate of stent thrombosis according the ARC (academic research consortium) criteria within 12 months post procedure.
The frequency of stent thrombosis will be compared in both study groups in 12 months follow-up.
Time frame: 12 months after the index procedure
Death or myocardial infarction within 12 months post procedure.
The frequency of death and myocardial infarction will be compared separately in both study groups in 12 months follow-up.
Time frame: 12 months after the index procedure