Study aim : To compare a novel strategy of lesion preparation with noncompliant balloons before implantation of BVS (Bioresorbable Vascular Scaffold). 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 ® 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
44
Target lesion will be prepared by predilatation with OPN NC balloon catheter.
Target lesion will be prepared by predilatation with standard balloon catheter (compliant).
After lesion preparation implantation of BVS Absorb scaffold will be performed.
Finally treated segment will be visualized by Intravascular Optical Coherence Tomography (OCT).
All patients will be clinically followed for 12 months.
Luzernen Kantonsspital, Spitalstrasse 16
Lucerne, Switzerland
Scaffold apposition ratio in both groups (ratio of malapossition stents to total stents per cross-section
Outcome will be analyzed by independent Angio CoreLab based on data recorded during index PCI procedure.
Time frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Procedural success defined as successful delivery of the scaffold
Time frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Need for post-dilatation after implantation of the scaffold
Time frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Scaffold apposition after post-dilatation
Outcome will be analyzed by independent Angio CoreLab based on data recorded during index PCI procedure.
Time frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Frequency and total number of periprocedural complications: dissection, slow- or no flow, dissection requiring additional stent implantation,
Time frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
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