NCT03548272

BiOSS LIM C vs 2nd Generation DES in Non-LM Bifurcations

POLish Bifurcation Optimal Treatment Strategy (POLBOS 3) Randomized Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 518 (estimated)
• Sponsor: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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)

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	Percutaneous Coronary Intervention with stent implantation	PCI with BiOSS LIM C or rDES depending on the randomization

Timeline

• Start date: 2018-06-12
• Primary completion: 2019-06-01
• Completion: 2020-06-01
• First posted: 2018-06-07
• Last updated: 2018-07-19

Locations

1 site across 1 country: Poland