NCT06284057

Lower Silesia Culotte Bifurcation Registry (LSCBR).

Double Kissing (DK) vs Culotte Culotte. Lower Silesia Culotte Bifurcation Registry (LSCBR).

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Regional Cardiology Center, The Copper Health Centre (MCZ), · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The study aimed to evaluate the outcomes of bifurcation PCI using two techniques (Culotte vs. DK-Culotte) using data from a retrospective analysis.

Detailed description

The study contains a retrospective analysis of subjects who have undergone PCI in two high-volume cooperative Cardiac Departments in the Lower Silesia Region (Poland) between April 2012 and January 2024. Data regarding all performed PCI from these periods were prescreened in terms of bifurcation lesion with subsequent implantation of two stents using the Culotte technique or the DK-Culotte technique. The indication for percutaneous coronary intervention (PCI) was based either on a judgment made by the Heart Team or on a particular clinical indication (ongoing ischemia, lack of will for the alternative treatment options, presence of significant angiographic CAD suitable for PCI due to ESC/ESH recommendation). The decision to perform the two-stent technique PCI was left to the operator's dissertation based on clinical and angiographical features. All patients were thoroughly informed about all therapeutic options and PCI-related risks before providing written informed consent for the procedure. There were no clinical or vessel-related exclusion criteria (lesion anatomy, length, tortuosity, severity). However, patients who had undergone PCI with coronary stents prior to the index procedure with respect to the bifurcation lesion studied were excluded from the study.

Conditions

• Safety Issues
• Efficacy, Self

Interventions

Type	Name	Description
PROCEDURE	Bifurcation PCI with two stent technique Culotte Technique or Double Kiss (DK) Culotte	Patient with CAD and coexisting bifurcation lesion requiring two-stent approach treated with Culotte Technique or Double Kiss (DK) Culotte due to operator distraction.

Timeline

• Start date: 2013-04-01
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2024-02-28
• Last updated: 2024-03-06

Locations

2 sites across 1 country: Poland