Coronary Artery Disease Clinical Trial
Official title:
POLish Bifurcation Optimal Treatment Strategy (POLBOS 3) Randomized Study
Coronary bifurcations are encountered in about 15 - 20% of percutaneous coronary interventions (PCI). They are considered technically challenging and associated with worse clinical outcomes than non-bifurcation lesions. Percutaneous coronary intervention (PCI) to the target bifurcation lesion. Randomization (by means envelope randomization) to investigational device: Group 1 for BiOSS LIM C implantation vs Group 2 for any DES implantation.
Single stent implantation in the main vessel-main branch across a side branch is the default
strategy (provisional T-stenting, PTS) in all patients enrolled. Bifurcation lesions are
assessed according to Medina classification using an index of 1 for stenosis greater than 50%
and 0 for no stenosis (visual estimation). There is no restriction regarding lesion length in
patient selection. If required, additional stent can be implanted (Alex Plus in the BiOSS Lim
C Group). A stent in a side branch (Alex Plus in the BiOSS Lim C Group) should be implanted
only if there is proximal residual stenosis greater than 70% after balloon dilatation and/or
significant flow impairment after main vessel - main branch stenting and/or a flow limiting
dissection.
The implantation protocol for bifurcation is as follows:
1. wiring of both branches;
2. main vessel predilatation and/or side branch predilatation according to the operator's
decision;
3. stent implantation (inflation for at least 20 s);
4. proximal optimization technique (POT)
5. side branch postdilatation/side branch stent implantation if necessary
6. final kissing balloon inflation at operator's discretion.
7. Second proximal optimization technique (re-POT)
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