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Clinical Trial Summary

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.


Clinical Trial Description

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) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03548272
Study type Interventional
Source Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
Contact
Status Not yet recruiting
Phase Phase 4
Start date June 2018
Completion date June 2020

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